19 Medical Safety Director jobs in the United Kingdom
Director,Medical Safety Officer,Established Products
High Wycombe, South East
J&J Family of Companies
Posted 20 days ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Product Safety
**Job Sub** **Function:**
Product Safety Risk Management MD
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Established Products to be located in High Wycombe, UK.
The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.
The MSO will report to the Therapeutic Area (TA) Safety Head and oversee the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.
**Responsibilities include, but are not limited to the following:**
Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products.
Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
Risk management plans.
Safety development plan.
Clinical Trial Protocols.
Informed Consent Forms (ICF).
Safety Sections of Investigatoru2019s Brochure (IB) and IB addenda.
Clinical Study Reports (CSR).
Annual Safety Reports (ASR).
Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings.
Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
Health authority queries.
Core Data Sheets (CDS).
Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.
Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:
Defining the safety question or issue requiring medical safety assessment.
Developing the strategy for the safety review and analysis.
Interpreting results and determining the medical importance of a question or issue.
Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports).
Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety assessment and risk management.
Lead or actively participate in department-wide initiatives.
Perform delegate responsibilities for other MSOs and/or SMT Chairs
**Education and Experience:**
Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
Board Certification (if US) preferred; Medical specialization preferred
Late phase and Post marketing experience preferred
Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
Ability to influence, negotiate and communicate with both internal and external stakeholders
Experience with Health Authority presentations is preferred.
**Required Technical Knowledge and Skills:**
Ability to effectively and strategically lead global cross-functional teams
Connect, collaborate and build consensus across relevant functions
Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business
Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
Able to plan work to meet deadlines and effectively handle multiple priorities
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
Fluent in written and spoken English
Proficiency in Word and PowerPoint is desired
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
**Job Function:**
Product Safety
**Job Sub** **Function:**
Product Safety Risk Management MD
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Established Products to be located in High Wycombe, UK.
The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.
The MSO will report to the Therapeutic Area (TA) Safety Head and oversee the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.
**Responsibilities include, but are not limited to the following:**
Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products.
Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
Risk management plans.
Safety development plan.
Clinical Trial Protocols.
Informed Consent Forms (ICF).
Safety Sections of Investigatoru2019s Brochure (IB) and IB addenda.
Clinical Study Reports (CSR).
Annual Safety Reports (ASR).
Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings.
Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
Health authority queries.
Core Data Sheets (CDS).
Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.
Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:
Defining the safety question or issue requiring medical safety assessment.
Developing the strategy for the safety review and analysis.
Interpreting results and determining the medical importance of a question or issue.
Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports).
Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety assessment and risk management.
Lead or actively participate in department-wide initiatives.
Perform delegate responsibilities for other MSOs and/or SMT Chairs
**Education and Experience:**
Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
Board Certification (if US) preferred; Medical specialization preferred
Late phase and Post marketing experience preferred
Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
Ability to influence, negotiate and communicate with both internal and external stakeholders
Experience with Health Authority presentations is preferred.
**Required Technical Knowledge and Skills:**
Ability to effectively and strategically lead global cross-functional teams
Connect, collaborate and build consensus across relevant functions
Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business
Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
Able to plan work to meet deadlines and effectively handle multiple priorities
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
Fluent in written and spoken English
Proficiency in Word and PowerPoint is desired
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
This advertiser has chosen not to accept applicants from your region.
0
Senior Safety Scientist / Associate Director / Director Safety Scientist
Welwyn, Eastern
Roche
Posted 2 days ago
Job Viewed
Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
**Join Roche as an Associate Director / Director / Senior Safety Scientist !**
We're looking for talented professionals at various experience levels. The position provides safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. A Senior Safety Scientist will be supported by supervision from one or more experienced colleagues but is expected to be able to work unsupervised on less complex deliverables. They will be expected to continue learning about Safety Science/Pharmacovigilance and the broader aspects of drug development.
**Key Responsibilities:**
Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues
+ Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
+ Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
+ Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
+ Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
+ Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
+ Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
+ Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead
+ Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
+ Responsible for coordination and collaboration with vendors servicing Safety Science
+ Take on the responsibility for appropriate specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
+ Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
+ Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
+ Ensures all actions are conducted in alignment with Roche quality management systems
+ Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
+ Trains and mentors more junior members of the safety team
+ Takes on leadership responsibility in order to manage and complete low to medium priority projects
+ Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
+ Consistently comply with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines
**Education, Skills and Experience**
+ Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate.
+ Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous
+ Safety scientist (level 2): proven drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
+ Understanding of GxP and regulated processes and end to end clinical trial lifecycle
+ Strong orientation towards process improvement and cross-functional teamwork
+ Effectively work with remote partners on a global team
+ Excellent communication skills, both written and verbal
+ Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
+ Good presentation skills, effective at summarizing and presenting the key considerations and decision points
+ Ability to train others on departmental practices and processes
+ Understanding of project management methodology
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
**The Position**
**Join Roche as an Associate Director / Director / Senior Safety Scientist !**
We're looking for talented professionals at various experience levels. The position provides safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. A Senior Safety Scientist will be supported by supervision from one or more experienced colleagues but is expected to be able to work unsupervised on less complex deliverables. They will be expected to continue learning about Safety Science/Pharmacovigilance and the broader aspects of drug development.
**Key Responsibilities:**
Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues
+ Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
+ Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
+ Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
+ Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
+ Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
+ Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
+ Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead
+ Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
+ Responsible for coordination and collaboration with vendors servicing Safety Science
+ Take on the responsibility for appropriate specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
+ Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
+ Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
+ Ensures all actions are conducted in alignment with Roche quality management systems
+ Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
+ Trains and mentors more junior members of the safety team
+ Takes on leadership responsibility in order to manage and complete low to medium priority projects
+ Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
+ Consistently comply with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines
**Education, Skills and Experience**
+ Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate.
+ Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous
+ Safety scientist (level 2): proven drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
+ Understanding of GxP and regulated processes and end to end clinical trial lifecycle
+ Strong orientation towards process improvement and cross-functional teamwork
+ Effectively work with remote partners on a global team
+ Excellent communication skills, both written and verbal
+ Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
+ Good presentation skills, effective at summarizing and presenting the key considerations and decision points
+ Ability to train others on departmental practices and processes
+ Understanding of project management methodology
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
This advertiser has chosen not to accept applicants from your region.
1
Associate Director / Director Safety Scientist
Welwyn Garden City, Eastern
Hays
Posted today
Job Viewed
Job Description
Your new company
My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for an Associate Director / Director Safety Scientist to join their team.
Hybrid - Office 8 times in a month
Your new role
As a highly motivated individual, you will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting, this may include signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management
- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
- Responsible for signal detection and management activities and contributing to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
- Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post-marketing studies), including PASS
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorisation Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with the team
- Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
- Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other guidelines
What you'll need to succeed
Primary life sciences degree and relevant postgraduate degree preferred
Proven drug safety, clinical development experience in the pharmaceutical industry, ideally as a Safety Scientist - including signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment, safety risk management and aggregate report writing.
Understanding of GxP and regulated processes and end-to-end clinical trial lifecycleStrong orientation towards process improvement and cross-functional teamwork
Excellent communication skills, both written and verbal
Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
Good presentation skills, effective at summarising and presenting the key considerations and decision points
Understanding of project management methodology
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on
This advertiser has chosen not to accept applicants from your region.
2
Assistant Director - Building Safety
Belfast, Northern Ireland
£78108 - £87820 Annually
Northern Ireland Housing Executive
Posted 1 day ago
Job Viewed
Job Description
Assistant Director - Building Safety (Ref )
Location: 2 Adelaide Street, Belfast, BT2 8PB
To lead the Housing Executive's approach to Building Safety and successfully manage a team of specialists to deliver building safety services to the wider organisation. To ensure regular reviews of our overall compliance approach are carried out and taking the lead on building safety work as new regulation and legislation come into being.
building safety services include the fulfilling of our statutory compliance functions (Gas, Electrical, Asbestos, Legionella, Fire etc) and delivering the outputs of the impending Building Safety Bill to our High Risk Residential Buildings.
The current salary for this post is £78,108 - £87,820 per annum. We also have an excellent pension scheme with an employer contribution of 19%.
All the information you need to apply is available in the Candidate Information Pack, which includes full details of the essential and desirable criteria.
This is available via clicking APPLY NOW
Applications will open on 28 August 2025 and the closing date for receipt of applications is 4:30 pm on Thursday 18 September 2025.
The Housing Executive is an equal opportunities employer. We particularly welcome applications from members of the Protestant community who are currently under represented in parts of our workforce.
This advertiser has chosen not to accept applicants from your region.
3
Associate Director,Device Safety Lead
High Wycombe, South East
J&J Family of Companies
Posted 8 days ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Product Safety
**Job Sub** **Function:**
Drug & Product Safety Operations
**Job Category:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**About Innovative Medicine:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
**We are searching for the best talent for an Associate Director, Device Safety Lead, J&J Innovative Medicine to be located in:**
Beerse, Antwerp / Belgium
Lisbon / Portugal
High Wycombe, Bucks / United Kingdom
Horsham, PA / United States
Raritan, NJ / United States
Titusville, NJ / United States
Toronto, ON / Canada
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Beerse, Belgium or Lisbon, Portual - Requisition Number: **R- **
USA, Horsham, PA, Titusville, NJ, or Raritan, NJ - Requisition Number: **R- **
Toronto, ON / Canada - Requisition Number: **R- **
**Purpose:**
The Device Safety Lead (DSL) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.
The DSL is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 13485/14971/20916.
Within this hybrid regulatory and compliance framework, the DSL is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.
In addition, the DSL will serve as a subject matter expert in their role for both internal consultations and audits/inspections, and participate in special projects and initiatives to streamline and optimize device processes and key metrics.
**You will be responsible for:**
ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
maintaining performance and risk metrics for device workflows that support strategic decision-making.
supporting special projects and initiatives as needed.
**Education:**
Bachelors degree in a Health Sciences or Engineering discipline is required
Masters degree or higher in a Health Sciences or Biomedical Engineering discipline is preferred
**Required:**
A minimum of 8 years of experience in pharmacovigilance, device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required
Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required
Ability to rapidly assimilate and apply new information for device assets and regulations is required
Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required
Strong written and verbal communication skills are required
Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required
The anticipated base pay range for this position is $137,000 - $35,750 USD.
The anticipated base pay range for this position is 106,000 - 246,100 CAD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companyu2019s long-term incentive program.
**Employees are eligible for the following time off benefits:**
Vacation u2013 up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington u2013 up to 56 hours per calendar year
Holiday pay, including Floating Holidays u2013 up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
**Job Function:**
Product Safety
**Job Sub** **Function:**
Drug & Product Safety Operations
**Job Category:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**About Innovative Medicine:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
**We are searching for the best talent for an Associate Director, Device Safety Lead, J&J Innovative Medicine to be located in:**
Beerse, Antwerp / Belgium
Lisbon / Portugal
High Wycombe, Bucks / United Kingdom
Horsham, PA / United States
Raritan, NJ / United States
Titusville, NJ / United States
Toronto, ON / Canada
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Beerse, Belgium or Lisbon, Portual - Requisition Number: **R- **
USA, Horsham, PA, Titusville, NJ, or Raritan, NJ - Requisition Number: **R- **
Toronto, ON / Canada - Requisition Number: **R- **
**Purpose:**
The Device Safety Lead (DSL) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.
The DSL is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 13485/14971/20916.
Within this hybrid regulatory and compliance framework, the DSL is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.
In addition, the DSL will serve as a subject matter expert in their role for both internal consultations and audits/inspections, and participate in special projects and initiatives to streamline and optimize device processes and key metrics.
**You will be responsible for:**
ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
maintaining performance and risk metrics for device workflows that support strategic decision-making.
supporting special projects and initiatives as needed.
**Education:**
Bachelors degree in a Health Sciences or Engineering discipline is required
Masters degree or higher in a Health Sciences or Biomedical Engineering discipline is preferred
**Required:**
A minimum of 8 years of experience in pharmacovigilance, device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required
Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required
Ability to rapidly assimilate and apply new information for device assets and regulations is required
Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required
Strong written and verbal communication skills are required
Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required
The anticipated base pay range for this position is $137,000 - $35,750 USD.
The anticipated base pay range for this position is 106,000 - 246,100 CAD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companyu2019s long-term incentive program.
**Employees are eligible for the following time off benefits:**
Vacation u2013 up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington u2013 up to 56 hours per calendar year
Holiday pay, including Floating Holidays u2013 up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
This advertiser has chosen not to accept applicants from your region.
4
Associate Director,Device Safety Lead
High Wycombe, South East
J&J Family of Companies
Posted 8 days ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Product Safety
**Job Sub** **Function:**
Drug & Product Safety Operations
**Job Category:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**About Innovative Medicine:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
**We are searching for the best talent for an Associate Director, Device Safety Lead, J&J Innovative Medicine to be located in:**
Beerse, Antwerp / Belgium
Lisbon / Portugal
High Wycombe, Bucks / United Kingdom
Horsham, PA / United States
Raritan, NJ / United States
Titusville, NJ / United States
Toronto, ON / Canada
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Beerse, Belgium or Lisbon, Portual - Requisition Number: **R- **
USA, Horsham, PA, Titusville, NJ, or Raritan, NJ - Requisition Number: **R- **
Toronto, ON / Canada - Requisition Number: **R- **
**Purpose:**
The Device Safety Lead (DSL) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.
The DSL is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 13485/14971/20916.
Within this hybrid regulatory and compliance framework, the DSL is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.
In addition, the DSL will serve as a subject matter expert in their role for both internal consultations and audits/inspections, and participate in special projects and initiatives to streamline and optimize device processes and key metrics.
**You will be responsible for:**
ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
maintaining performance and risk metrics for device workflows that support strategic decision-making.
supporting special projects and initiatives as needed.
**Education:**
Bachelors degree in a Health Sciences or Engineering discipline is required
Masters degree or higher in a Health Sciences or Biomedical Engineering discipline is preferred
**Required:**
A minimum of 8 years of experience in pharmacovigilance, device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required
Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required
Ability to rapidly assimilate and apply new information for device assets and regulations is required
Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required
Strong written and verbal communication skills are required
Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required
The anticipated base pay range for this position is $137,000 - $35,750 USD.
The anticipated base pay range for this position is 106,000 - 246,100 CAD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companyu2019s long-term incentive program.
**Employees are eligible for the following time off benefits:**
Vacation u2013 up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington u2013 up to 56 hours per calendar year
Holiday pay, including Floating Holidays u2013 up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
**Job Function:**
Product Safety
**Job Sub** **Function:**
Drug & Product Safety Operations
**Job Category:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**About Innovative Medicine:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
**We are searching for the best talent for an Associate Director, Device Safety Lead, J&J Innovative Medicine to be located in:**
Beerse, Antwerp / Belgium
Lisbon / Portugal
High Wycombe, Bucks / United Kingdom
Horsham, PA / United States
Raritan, NJ / United States
Titusville, NJ / United States
Toronto, ON / Canada
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Beerse, Belgium or Lisbon, Portual - Requisition Number: **R- **
USA, Horsham, PA, Titusville, NJ, or Raritan, NJ - Requisition Number: **R- **
Toronto, ON / Canada - Requisition Number: **R- **
**Purpose:**
The Device Safety Lead (DSL) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.
The DSL is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 13485/14971/20916.
Within this hybrid regulatory and compliance framework, the DSL is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.
In addition, the DSL will serve as a subject matter expert in their role for both internal consultations and audits/inspections, and participate in special projects and initiatives to streamline and optimize device processes and key metrics.
**You will be responsible for:**
ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
maintaining performance and risk metrics for device workflows that support strategic decision-making.
supporting special projects and initiatives as needed.
**Education:**
Bachelors degree in a Health Sciences or Engineering discipline is required
Masters degree or higher in a Health Sciences or Biomedical Engineering discipline is preferred
**Required:**
A minimum of 8 years of experience in pharmacovigilance, device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required
Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required
Ability to rapidly assimilate and apply new information for device assets and regulations is required
Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required
Strong written and verbal communication skills are required
Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required
The anticipated base pay range for this position is $137,000 - $35,750 USD.
The anticipated base pay range for this position is 106,000 - 246,100 CAD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companyu2019s long-term incentive program.
**Employees are eligible for the following time off benefits:**
Vacation u2013 up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington u2013 up to 56 hours per calendar year
Holiday pay, including Floating Holidays u2013 up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicantsu2019 needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
This advertiser has chosen not to accept applicants from your region.
5
Associate Director Drug Safety Scientist
London, London
Cpl
Posted today
Job Viewed
Job Description
CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.
As a Safety Scientist, you key responsibilities will include:
- Support safety activities in early and late-phase clinical development
- Conduct signal detection, evaluation, and contribute to risk-benefit assessments
- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)
- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)
- Contribute to the development and maintenance of safety labeling and core safety documents
- Collaborate with internal teams and external partners to ensure high-quality safety deliverables
- Provide safety input to study teams and participate in cross-functional meetings
- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities
Hybrid: North London 2 days per week on site, 3 days remote
Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.
Strong analytical, communication, and collaboration skills are essential for success in this role.
This advertiser has chosen not to accept applicants from your region.
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6
Associate Director Drug Safety Scientist
Cpl
Posted today
Job Viewed
Job Description
CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.
As a Safety Scientist, you key responsibilities will include:
- Support safety activities in early and late-phase clinical development
- Conduct signal detection, evaluation, and contribute to risk-benefit assessments
- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)
- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)
- Contribute to the development and maintenance of safety labeling and core safety documents
- Collaborate with internal teams and external partners to ensure high-quality safety deliverables
- Provide safety input to study teams and participate in cross-functional meetings
- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities
Hybrid: North London 2 days per week on site, 3 days remote
Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.
Strong analytical, communication, and collaboration skills are essential for success in this role.
This advertiser has chosen not to accept applicants from your region.
7
Associate Director, Safety Project Leadership and Strategic Solutions
Reading, South East
IQVIA
Posted 10 days ago
Job Viewed
Job Description
**Lifecycle Safety Project Management team** manages the delivery of lifecycle safety from trial initiation to closeout. Ensures quality deliverables are presented on time and within budget; coordinates work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.
As an **Associate Director, Safety Project Leadership and Strategic Solutions** , you will provide strategic leadership at customer account level for multiple large projects, as assigned by senior management team. Act as Sponsor's primary point of contact throughout project duration for local and globally scoped deliverables (programs) with single/multiple Lifecycle Safety functions. Collaborate with global management team to develop and implement strategic initiatives and ensure global consistency.
**Main Responsibilities**
+ Manage the delivery of lifecycle safety from trial initiation to closeout, ensuring quality deliverables are presented on time and within budget.
+ Coordinate work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies.
+ Identify and evaluate potential project risks and develop mitigation plans.
+ Serve as the primary point of contact with the project sponsor.
+ Collaborate with the global management team to develop and implement strategic initiatives and ensure global consistency.
+ Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities and drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence, and excellent customer communication.
+ Manage scope and budget review and finalization with sponsors, ensuring program financial targets are met.
+ Accountable for oversight of Lifecycle Safety performance for projects/programs on assigned accounts, including customer interface and communications, customer deliverables, realization/profitability, service integration, and technical solutions.
+ Prepare, present, and respond in bid defense meetings and discussions, and input into more complex requests for information (RFIs) or requests for proposal (RFPs).
+ Liaise with Business Development to provide timely inputs regarding the feasibility of new proposals going out to clients.
+ Contribute at IQVIA internal cross-functional project team meetings, interfacing with other functional leads, customer project status meetings, and oversight group meetings.
**Minimum Required Education and Experience**
- Bachelor's Degree Health science or other directly related field.
- 8 years' Clinical Research experience in a Contract Research Organization or Pharmaceutical company combining 5 years of Lifecycle Safety experience (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) or equivalent combination of education, training or experience.
- In depth knowledge and understanding of Lifecycle Safety service lines.
**Skills and Abilities**
- Strong business acumen; financial management and budgeting skills.
- Strong project management; strategic planning; delegation and organisational skills.
- Proven ability to work on multiple projects and manage competing priorities.
- Strong leadership, motivational and influencing skills.
- Strong customer focus.
- Demonstrates financial awareness. Promotes good practices to manage financial performance.
- Excellent communication, presentation and negotiation skills.
- Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level.
- Autonomous independent decision-making; problem solving and judgment skills.
- Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities.
- Strong ownership skills: take initiative and move forward with limited guidance. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations.
**This role is not available for a UK visa sponsorship.**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
As an **Associate Director, Safety Project Leadership and Strategic Solutions** , you will provide strategic leadership at customer account level for multiple large projects, as assigned by senior management team. Act as Sponsor's primary point of contact throughout project duration for local and globally scoped deliverables (programs) with single/multiple Lifecycle Safety functions. Collaborate with global management team to develop and implement strategic initiatives and ensure global consistency.
**Main Responsibilities**
+ Manage the delivery of lifecycle safety from trial initiation to closeout, ensuring quality deliverables are presented on time and within budget.
+ Coordinate work streams and efforts of cross-functional project teams while monitoring the use of consistent tools and methodologies.
+ Identify and evaluate potential project risks and develop mitigation plans.
+ Serve as the primary point of contact with the project sponsor.
+ Collaborate with the global management team to develop and implement strategic initiatives and ensure global consistency.
+ Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities and drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence, and excellent customer communication.
+ Manage scope and budget review and finalization with sponsors, ensuring program financial targets are met.
+ Accountable for oversight of Lifecycle Safety performance for projects/programs on assigned accounts, including customer interface and communications, customer deliverables, realization/profitability, service integration, and technical solutions.
+ Prepare, present, and respond in bid defense meetings and discussions, and input into more complex requests for information (RFIs) or requests for proposal (RFPs).
+ Liaise with Business Development to provide timely inputs regarding the feasibility of new proposals going out to clients.
+ Contribute at IQVIA internal cross-functional project team meetings, interfacing with other functional leads, customer project status meetings, and oversight group meetings.
**Minimum Required Education and Experience**
- Bachelor's Degree Health science or other directly related field.
- 8 years' Clinical Research experience in a Contract Research Organization or Pharmaceutical company combining 5 years of Lifecycle Safety experience (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) or equivalent combination of education, training or experience.
- In depth knowledge and understanding of Lifecycle Safety service lines.
**Skills and Abilities**
- Strong business acumen; financial management and budgeting skills.
- Strong project management; strategic planning; delegation and organisational skills.
- Proven ability to work on multiple projects and manage competing priorities.
- Strong leadership, motivational and influencing skills.
- Strong customer focus.
- Demonstrates financial awareness. Promotes good practices to manage financial performance.
- Excellent communication, presentation and negotiation skills.
- Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level.
- Autonomous independent decision-making; problem solving and judgment skills.
- Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities.
- Strong ownership skills: take initiative and move forward with limited guidance. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations.
**This role is not available for a UK visa sponsorship.**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
8
Solution Director - Public Safety and Defence
London, London
NTT America, Inc.
Posted 10 days ago
Job Viewed
Job Description
**The team you'll be working with:**
Our Public Sector Business Unit is growing strongly, and we are looking for experienced pre-sales solution directors to join the team. We are looking for highly motivated individuals who are capable of working at pace: rapidly getting up to speed with new requirements and shaping compelling, innovative and differentiated solutions for our customers.
You will ideally have a background in the Public Sector, preferably for a consultancy or systems integrator, and have successfully led solution aspects of bid responses, presentations and customer discussions. You will be a strong communicator, capable of generating written material of extremely high quality and presenting confidently. You will be comfortable with a wide range of technologies and solution types with a perspective that is broad rather than deep in any specific area. You will have a strong commercial understanding and be able to balance financial and budgetary constraints with customer aspirations. You will be used to working a fast-changing environment, forming new teams quickly, bringing organisation and structure where there is ambiguity and building strong working relationships.
**What you'll be doing:**
You will be responsible for leading the pre-sales activity; typically as part of a formal procurement (e.g. RFx) or in support of a proactive campaign. You will be pivotal to the response, responsible for delivering an integrated solution and a coordinated delivery plan across all technology domains and business practices. You will be authoring your own content, as well as orchestrating and aligning content from across the business. You'll lead the generation of thought leadership, and be capable of developing innovative propositions that will differentiate us within the market.
Your primary objectives will be to:
+ quickly distil customer needs or goals into a simple vision and story board that can act as a central pivot for the pre-sales team
+ author creative and persuasive pre-sales content and thought leadership
+ lead solution aspects of client pitches and negotiations
+ collate, orchestrate, and refine content to create a cohesive solution and delivery model
+ use your experience to influence and challenge the solutions we present
+ promote and develop pre-sales governance and best practices
+ build and leverage a wide senior-level network to navigate the global delivery organisation
+ develop capability; building momentum across the organisation to create a virtual team of creative content-writers, with great communication skills and strong commercial awareness
+ develop close relationships with key customer stakeholders, influencing and supporting our clients' technical strategies
+ optimise knowledge; creating quality content that can be reused, building continual improvement into our knowledge estate and pre-sales assets
**What experience you'll bring:**
To take advantage of this opportunity you will need to be a highly structured individual with solid technical background and the ability to lead people and orchestrate multiple points of view. Experience in both delivery and operational roles would be beneficial.
+ You must be comfortable operating with high levels of ambiguity, you must have the ability to be bold, bring clarity and build confidence in our understanding of each opportunity
+ Your experience will enable you to tap into your innate knowledge to rapidly qualify opportunities and provide a view on complexity, opportunity size and risk
+ You must be able to unravel business ideas and get to the root of real business value to help our technical architects and business consultants create solutions that will excite our clients
+ Working with a global network of inspiring technologists, you must be able to harness talent from across the NTT Data family to generate solution collateral
+ Whilst working alongside technology and business experts, you must be familiar working with reference architectures and high-level technology patterns & designs
+ The role will demand you to be a strong influencer, having the ability to build good working relationships with delivery partners at all levels within the organisation
+ You must be a great visual storyteller, able to bring solutions to life to help our customers understand and embrace the value of change & technology
**Education and Experience**
+ 10+ years of technical delivery experience on complex engagements, at least some of which has been within the UK Public Sector
+ Sales or pre-sales experience, either in a direct presale / sales role or as part of meeting management responsibilities
+ The ability to build effective teams, recognising people's strengths and weaknesses and establishing the right environment for growth
+ Excellent knowledge of the entire software development lifecycle and in delivery of software products
+ Experience with agile development methods & tooling e.g. Scrum, Kanban, Scaled Agile Framework, GDS Service Standard, Jira & Confluence
+ Understanding of architectural concepts, across application, cloud infrastructure, data, and integration
+ Experience in managed services or operational environments (such as defining service architectures) would also be advantageous
**Who we are:**
We're a business with a global reach that empowers local teams, and we undertake hugely exciting work that is genuinely changing the world. Our advanced portfolio of consulting, applications, business process, cloud, and infrastructure services will allow you to achieve great things by working with brilliant colleagues, and clients, on exciting projects.
Our inclusive work environment prioritises mutual respect, accountability, and continuous learning for all our people. This approach fosters collaboration, well-being, growth, and agility, leading to a more diverse, innovative, and competitive organisation. We are also proud to share that we have a range of Inclusion Networks such as: the Women's Business Network, Cultural and Ethnicity Network, LGBTQ+ & Allies Network, Neurodiversity Network and the Parent Network.
For more information on Diversity, Equity and Inclusion please click here: Creating Inclusion Together at NTT DATA UK | NTT DATA ( we'll offer you:**
We offer a range of tailored benefits that support your physical, emotional, and financial wellbeing. Our Learning and Development team ensure that there are continuous growth and development opportunities for our people. We also offer the opportunity to have flexible work options.
You can find more information about NTT DATA UK & Ireland here: are an equal opportunities employer. We believe in the fair treatment of all our employees and commit to promoting equity and diversity in our employment practices. We are also a proud Disability Confident Committed Employer - we are committed to creating a diverse and inclusive workforce. We actively collaborate with individuals who have disabilities and long-term health conditions which have an effect on their ability to do normal daily activities, ensuring that barriers are eliminated when it comes to employment opportunities. In line with our commitment, we guarantee an interview to applicants who declare to us, during the application process, that they have a disability and meet the minimum requirements for the role. If you require any reasonable adjustments during the recruitment process, please let us know. Join us in building a truly diverse and empowered team.
**Job Advert Attachment:**
Public_Sector_Solution_Director_Job_Spec_v1.docx
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Our Public Sector Business Unit is growing strongly, and we are looking for experienced pre-sales solution directors to join the team. We are looking for highly motivated individuals who are capable of working at pace: rapidly getting up to speed with new requirements and shaping compelling, innovative and differentiated solutions for our customers.
You will ideally have a background in the Public Sector, preferably for a consultancy or systems integrator, and have successfully led solution aspects of bid responses, presentations and customer discussions. You will be a strong communicator, capable of generating written material of extremely high quality and presenting confidently. You will be comfortable with a wide range of technologies and solution types with a perspective that is broad rather than deep in any specific area. You will have a strong commercial understanding and be able to balance financial and budgetary constraints with customer aspirations. You will be used to working a fast-changing environment, forming new teams quickly, bringing organisation and structure where there is ambiguity and building strong working relationships.
**What you'll be doing:**
You will be responsible for leading the pre-sales activity; typically as part of a formal procurement (e.g. RFx) or in support of a proactive campaign. You will be pivotal to the response, responsible for delivering an integrated solution and a coordinated delivery plan across all technology domains and business practices. You will be authoring your own content, as well as orchestrating and aligning content from across the business. You'll lead the generation of thought leadership, and be capable of developing innovative propositions that will differentiate us within the market.
Your primary objectives will be to:
+ quickly distil customer needs or goals into a simple vision and story board that can act as a central pivot for the pre-sales team
+ author creative and persuasive pre-sales content and thought leadership
+ lead solution aspects of client pitches and negotiations
+ collate, orchestrate, and refine content to create a cohesive solution and delivery model
+ use your experience to influence and challenge the solutions we present
+ promote and develop pre-sales governance and best practices
+ build and leverage a wide senior-level network to navigate the global delivery organisation
+ develop capability; building momentum across the organisation to create a virtual team of creative content-writers, with great communication skills and strong commercial awareness
+ develop close relationships with key customer stakeholders, influencing and supporting our clients' technical strategies
+ optimise knowledge; creating quality content that can be reused, building continual improvement into our knowledge estate and pre-sales assets
**What experience you'll bring:**
To take advantage of this opportunity you will need to be a highly structured individual with solid technical background and the ability to lead people and orchestrate multiple points of view. Experience in both delivery and operational roles would be beneficial.
+ You must be comfortable operating with high levels of ambiguity, you must have the ability to be bold, bring clarity and build confidence in our understanding of each opportunity
+ Your experience will enable you to tap into your innate knowledge to rapidly qualify opportunities and provide a view on complexity, opportunity size and risk
+ You must be able to unravel business ideas and get to the root of real business value to help our technical architects and business consultants create solutions that will excite our clients
+ Working with a global network of inspiring technologists, you must be able to harness talent from across the NTT Data family to generate solution collateral
+ Whilst working alongside technology and business experts, you must be familiar working with reference architectures and high-level technology patterns & designs
+ The role will demand you to be a strong influencer, having the ability to build good working relationships with delivery partners at all levels within the organisation
+ You must be a great visual storyteller, able to bring solutions to life to help our customers understand and embrace the value of change & technology
**Education and Experience**
+ 10+ years of technical delivery experience on complex engagements, at least some of which has been within the UK Public Sector
+ Sales or pre-sales experience, either in a direct presale / sales role or as part of meeting management responsibilities
+ The ability to build effective teams, recognising people's strengths and weaknesses and establishing the right environment for growth
+ Excellent knowledge of the entire software development lifecycle and in delivery of software products
+ Experience with agile development methods & tooling e.g. Scrum, Kanban, Scaled Agile Framework, GDS Service Standard, Jira & Confluence
+ Understanding of architectural concepts, across application, cloud infrastructure, data, and integration
+ Experience in managed services or operational environments (such as defining service architectures) would also be advantageous
**Who we are:**
We're a business with a global reach that empowers local teams, and we undertake hugely exciting work that is genuinely changing the world. Our advanced portfolio of consulting, applications, business process, cloud, and infrastructure services will allow you to achieve great things by working with brilliant colleagues, and clients, on exciting projects.
Our inclusive work environment prioritises mutual respect, accountability, and continuous learning for all our people. This approach fosters collaboration, well-being, growth, and agility, leading to a more diverse, innovative, and competitive organisation. We are also proud to share that we have a range of Inclusion Networks such as: the Women's Business Network, Cultural and Ethnicity Network, LGBTQ+ & Allies Network, Neurodiversity Network and the Parent Network.
For more information on Diversity, Equity and Inclusion please click here: Creating Inclusion Together at NTT DATA UK | NTT DATA ( we'll offer you:**
We offer a range of tailored benefits that support your physical, emotional, and financial wellbeing. Our Learning and Development team ensure that there are continuous growth and development opportunities for our people. We also offer the opportunity to have flexible work options.
You can find more information about NTT DATA UK & Ireland here: are an equal opportunities employer. We believe in the fair treatment of all our employees and commit to promoting equity and diversity in our employment practices. We are also a proud Disability Confident Committed Employer - we are committed to creating a diverse and inclusive workforce. We actively collaborate with individuals who have disabilities and long-term health conditions which have an effect on their ability to do normal daily activities, ensuring that barriers are eliminated when it comes to employment opportunities. In line with our commitment, we guarantee an interview to applicants who declare to us, during the application process, that they have a disability and meet the minimum requirements for the role. If you require any reasonable adjustments during the recruitment process, please let us know. Join us in building a truly diverse and empowered team.
**Job Advert Attachment:**
Public_Sector_Solution_Director_Job_Spec_v1.docx
Back to search Email to a friend Apply now
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