23 Drug Safety Associate jobs in the United Kingdom
Associate Director Drug Safety Scientist
Posted today
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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.
Associate Director Drug Safety Scientist
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.
Associate Director Drug Safety Scientist
Posted today
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Associate Director Drug Safety Scientist
Posted today
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Clinical Safety Officer
Posted today
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Job Role Overview
Clinical Safety Officer - This opening is to join one of the foremost strategy, risk and compliance providers in the UK. We are looking for an experienced Clinical Safety Officer (CSO) to support our growing international client base.
About The AbedGraham Group
Established over a decade ago, The AbedGraham Group has grown in to one of the most trusted consultancies for technology companies and government agencies. We provide a range of strategic, marketing, project management and compliance services for health IT, security, medical device and network infrastructure vendors. Within our compliance service set, we provide DCB0129, Digital Technology Assessment Criteria (DTAC), Data Security and Protection toolkit (DSPT) and cybersecurity services for dozens of the industry’s leading companies.
About the Job
The job role is to join the compliance team at The AbedGraham Group in the capacity of Clinical Safety Officer. Within the NHS, all suppliers of digital technologies that impact patient care are obliged to comply with the mandatory DCB0129 standard and complete DTAC submissions for review by purchasing organisations or regulators. The AbedGraham Group assists dozens of companies with these processes and frequently acts as the Clinical Safety Officer on their behalf. You will be working under the COO to help maintain existing clients’ compliance and ensuring new clients’ requirements are met. Our compliance work extends across a huge range of specialties from primary to secondary to community and mental health care and across dozens of healthcare IT verticals including EHR, document management, radiology, psychiatry, remote monitoring, online and video consultations, community testing, speech recognition and digital dictation, genomics and surgery.
Essential Requirements
- A registered clinician with a UK professional body with at least 2 years’ experience
- An approved Clinical Safety Officer (that is either evidence of NHS Digital’s risk course attendance or a similar accreditation)
- At least 2 years’ experience in either creating or reviewing the standard documents within DCB0129 (clinical safety case report, hazard log, clinical risk management plan/system)
- Knowledge of clinical informatics and its application in multiple healthcare environments
- Knowledge of ongoing compliance requirements (software testing, release reviews, incident management)
- Exceptional communication and documentation skills
- Exceptional productivity and efficiency
Desirable Requirements
- Experience with companies who have Artificial Intelligence (AI) as part of their product set
- Knowledge or experience of medical device regulations including ISO13485 and ISO14971
- Knowledge or experience of deploying healthcare technologies in line with DCB0160 best principles
- Knowledge of wider DTAC competencies (security, data protection, interoperability)
- Experience in or working with NHS Digital or regional/national procurements/rollouts
- Experience with medical device regulation
The Offer
- Fully remote working
- Competitive Salary
- Up to 10% bonus annually
- Private healthcare cover
- Company pension
- All professional training/accreditation requirements and costs covered
- All IT requirements and costs covered
Finally the opportunity for job growth is important to us. The right candidate can expect the responsibility of managing our clients’ work themselves as well as overseeing the work of others in due course. A more strategic role, reporting to the executive board, will also be considered after 12 months. Please send all submissions and CVs to , we look forward to speaking with you and for you to join us on this exciting journey!
Clinical Safety Officer
Posted today
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Senior Regulatory Affairs Specialist - Drug Safety
Posted 2 days ago
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- Manage and oversee regulatory submissions related to drug safety, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and periodic safety update reports (PSURs).
- Ensure compliance with global pharmacovigilance regulations (e.g., GVP Modules, FDA regulations) and company policies.
- Prepare, review, and submit safety-related regulatory documents to health authorities worldwide.
- Liaise with global regulatory agencies to address queries and provide necessary information regarding drug safety.
- Collaborate closely with internal departments, including Clinical Development, Medical Affairs, and Quality Assurance, to ensure integrated safety reporting and compliance.
- Monitor regulatory changes and assess their impact on company products and processes.
- Develop and maintain regulatory submission documentation and databases.
- Contribute to the development and implementation of company SOPs related to regulatory affairs and drug safety.
- Provide expert advice and guidance on regulatory requirements to cross-functional teams.
- Participate in regulatory inspections and audits, ensuring preparedness and compliance.
- Support post-marketing safety surveillance activities and submissions.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or equivalent is highly preferred.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry, with a specialization in drug safety/pharmacovigilance.
- Thorough understanding of global regulatory requirements for drug safety and GxP.
- Proven experience in preparing and submitting safety-related regulatory documents.
- Excellent knowledge of pharmacovigilance principles and reporting requirements.
- Strong analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Proficiency in regulatory information management systems and safety databases.
- Ability to work independently, manage multiple priorities, and meet strict deadlines.
- Attention to detail and a commitment to maintaining the highest standards of compliance.
- Candidates must be based in or willing to relocate to the Brighton, East Sussex, UK area for this office-based position.
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Senior Safety Scientist / Associate Director / Director Safety Scientist
Posted 5 days ago
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**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.
Research Associate - Safety Pharmacology
Posted 1 day ago
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**Do you want to be responsible for the collection of data within our Cardiovascular Safety Pharmacology group?**
**Are you analytical and have excellent attention to detail?**
As one of the world's premier Contract Research Organisations, Labcorp's mission is to help build a healthier and safer world by providing research services for a multitude of organizations.
We strive to make a difference to people's everyday lives by bringing essential products to the market and as a **Research Associate** at our site **Harrogate, North Yorkshire,** you will play an essential part in making this happen.
In this role you will be providing technical support along with acquiring and analysing data in compliance with appropriate SOPs, GLPs, Home Office Licence requirements and regulatory agency guidelines. You will also be required to set up and maintain equipment.
This is a great opportunity for someone with previous experience in this area or someone who has previously worked with animals in industry and is looking to progress their scientific career. Your time will be spent in the animal units and office.
**The main responsibilities will include:**
+ Recording and analysing electronic data
+ Adhering to strict timelines for on time delivery of data for the team
+ Assisting with preparation of laboratory equipment for the team
+ Checking the accuracy of the data collected and ensuring this is put into specified formats
**You will:**
+ Learn data collection and analysis
+ Demonstrate basic understanding of ECG and blood pressure waveforms
+ Learn to recognize typical ECG complexes, basic ECG rhythms, and typical abnormal rhythms
+ Following training as applicable, provide technical and scientific support for data acquisition and analysis of data in accordance with the study protocol, regulatory guidelines, SOPs and needs of study direction
+ Learn or have an understanding of legality of use of animals in research (PIL A) and ASPA as relevant to role
+ Hold or obtain a Home Office Licence Modules 1-3
+ Learn to follow and understand all department specific SOPs, processes and best practices relevant to role
+ Gain familiarity with protocol requirements and Project Licenses as relevant to role
+ Begin to develop ability to review and provide input on protocols, amendments and reports for all relevant study types.
+ Data checking to ensure compliance with SOPs, Good Laboratory Practice (GLP) and reporting of any deviations
+ Begin to develop ability to monitor critical phases of studies and reports problems to the study management team
+ Understands study schedules and assists in the inter-department scheduling of studies as assigned
**What Labcorp can offer you:**
+ A competitive salary together with a comprehensive benefits package including health cover and pension
+ Unsurpassed career development opportunities supported by exceptional people from across the globe with an energized purpose
+ Ability to work with a variety of different clients on wide ranging projects
+ A culture of CARE with access to well-being programs and various employee resource groups
**Education:**
+ Minimum A Levels in related science field. Associate degree in Laboratory Animal Technology, or Associate degree in Veterinary Technology or a relevant BTEC advantageous
+ Home Office licence is preferred
+ Experience may be substituted for education requirements
**Skills / Experience:**
+ Previous scientific work experience desirable along with data acquisition and analysis, preferably working to GLP
+ Strong team player
+ Able to quickly learn new tasks and methodologies
+ Proficient with computers and software programs, specifically ability to learn ones utilized for departmental data collection and analysis
If you are looking to work within a supportive team, where there are real opportunities to learn, develop and progress then we would like to hear from you!
**Labcorp is proud to be an Equal Opportunity Employer:**
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
**We encourage all to apply**
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Associate / Managing Associate Product Safety Lawyer
Posted 1 day ago
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THE OPPORTUNITY
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
Our client, a Tier 1 Product Safety & Product Liability practice based in London, is seeking an experienced qualified lawyer to join their dynamic and highly regarded disputes team. This is an exceptional opportunity to work at the forefront of complex, high-profile product liability claims, group actions, and regulatory/safety advice, including coordinating product recalls across
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