423 Senior Pharmacovigilance Scientist jobs in the United Kingdom
Pharmacovigilance Scientist Manager
Posted today
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At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**PHARMACOVIGILANCE SCIENTIST MANAGER**
**What you will do**
**In this vital role the Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.**
+ Contribute to the planning, preparation, writing and review of non-medical portions of aggregate reports
+ Work with affiliates and other internal Amgen partners regarding deliverables
+ Review of AE/SAEs from clinical trials as needed
+ Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
+ Review standard design of tables, figures, and listings for safety data from clinical studies
+ Participate in development of safety-related data collection forms for clinical studies
+ Attend study team meetings as requested or needed
+ Conduct signal detection, evaluation, and management
+ Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
+ Prepare safety assessment reports and other safety documents and regulatory responses
+ Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
+ Participates in Safety Governance per Amgen processes
+ Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
+ Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
+ Provide contents for risk management plans
+ Update strategy and content for regional risk management plans
+ Assist GSOs to coordinate risk minimization activities including tracking of activities as needed
+ Evaluate risk minimization activity
+ Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
+ Support activities related to new drug applications and other regulatory filings
+ Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
+ Provide safety contents for filings
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications.
+ Degree educated with directly relevant Global Patient Safety experience
+ Clinical/medical research experience
+ Experience in a biotech/pharmaceutical setting
+ Strong technical competency
+ Strong attention to detail and time management
+ Strong written communication
+ Strong planning and problem solving skills
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote setting may be considered
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Principal Pharmacovigilance Scientist
Posted 3 days ago
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Job Description
Key Responsibilities:
- Lead the detection, assessment, and management of safety signals for assigned products.
- Author and review regulatory safety reports (e.g., PBRERs, DSURs, IND/NDA safety updates).
- Contribute to the development and execution of pharmacovigilance strategies and plans.
- Collaborate with cross-functional teams to ensure integrated safety assessments.
- Interpret and apply global pharmacovigilance regulations and guidelines.
- Develop and update pharmacovigilance SOPs and training materials.
- Provide expert input into risk management plans and benefit-risk assessments.
- Participate in regulatory agency interactions regarding product safety.
- Mentor junior members of the pharmacovigilance team.
- Advanced degree (MSc, PhD, MD, PharmD) in a life science or medical field.
- Significant experience in pharmacovigilance and drug safety.
- Proven expertise in signal detection, risk management, and regulatory reporting.
- Thorough knowledge of global regulatory requirements for pharmacovigilance.
- Excellent analytical, written, and verbal communication skills.
- Ability to manage multiple projects and deadlines in a complex environment.
- Experience with safety databases and pharmacovigilance software.
- Strong understanding of clinical trial processes and pharmaceutical development.
Senior Pharmacovigilance Scientist
Posted 10 days ago
Job Viewed
Job Description
Key Responsibilities:
- Perform signal detection and evaluation activities, identifying potential safety issues for assigned products.
- Contribute to the preparation and review of aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Collaborate with regulatory affairs, clinical development, and medical affairs teams to ensure timely and accurate safety reporting.
- Assess and process individual case safety reports (ICSRs), ensuring compliance with regulatory timelines and standards.
- Contribute to the development and maintenance of the company's safety database.
- Participate in risk management planning and implementation for assigned products.
- Support regulatory authority inspections and internal audits related to pharmacovigilance.
- Review and analyze clinical trial data for safety signals.
- Develop and deliver pharmacovigilance training to internal stakeholders.
- Stay current with global pharmacovigilance regulations, guidelines, and best practices.
- Contribute to the writing and revision of Company Core Data Sheets (CCDS) and Investigator Brochures.
- Advanced scientific degree (MSc, PhD, PharmD) in a relevant life science discipline.
- Minimum of 5 years of experience in pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global ICH guidelines, GVP modules, and regulatory requirements for safety reporting (e.g., FDA, EMA).
- Proven experience in signal detection, aggregate reporting, and case processing.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to articulate complex scientific information.
- Proficiency with pharmacovigilance databases and safety reporting systems.
- Ability to work independently and collaboratively in a remote team environment.
- Detail-oriented with a strong commitment to accuracy and compliance.
Senior Pharmacovigilance Scientist
Posted 11 days ago
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Job Description
Key responsibilities include conducting in-depth safety data analysis, signal detection, and risk assessment. You will contribute to the development and maintenance of aggregate safety reports, such as Periodic Benefit-Risk Evaluations (PBRERs) and DSURs. The Senior Pharmacovigilance Scientist will also play a crucial role in developing and implementing pharmacovigilance strategies, standard operating procedures (SOPs), and training materials. You will liaise with internal departments, including clinical development, regulatory affairs, and medical affairs, as well as external stakeholders, such as healthcare professionals and regulatory authorities. Participating in internal and external audits and inspections will also be part of your remit.
The ideal candidate will possess a scientific degree (e.g., Pharmacy, Medicine, Life Sciences) or equivalent experience, with a minimum of 5 years of progressive experience in pharmacovigilance. A thorough understanding of global pharmacovigilance regulations, guidelines (ICH, CIOMS), and reporting requirements is essential. Strong analytical skills, proficiency in safety databases (e.g., Argus, ARISg), and experience with medical coding dictionaries (e.g., MedDRA, WHO-DD) are required. Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely, are paramount. The ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote work environment is crucial. A proactive approach to problem-solving and a commitment to patient safety are highly valued. This role offers a significant opportunity to influence drug safety strategies within a forward-thinking organization.
Senior Pharmacovigilance Scientist
Posted 14 days ago
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Job Description
Responsibilities:
- Conduct comprehensive safety data analysis and signal detection activities for assigned products.
- Prepare and review Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory safety documents.
- Manage and assess spontaneous and solicited adverse event reports, ensuring compliance with global regulatory requirements.
- Contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk-Benefit Assessments.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, on safety-related matters.
- Participate in the review of clinical trial protocols, investigator brochures, and clinical study reports from a safety perspective.
- Support regulatory interactions and submissions related to product safety.
- Stay updated on pharmacovigilance regulations, guidelines, and industry best practices.
- Mentor junior members of the pharmacovigilance team.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Advanced degree (MSc, PhD, PharmD) in a life science, healthcare, or related discipline.
- Minimum of 4-6 years of direct experience in pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines).
- Demonstrated experience in signal detection, safety data analysis, and aggregate report writing.
- Proficiency with safety databases (e.g., Argus Safety, ArisG) and case processing.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present complex safety information clearly.
- Experience working in a cross-functional team environment.
- Ability to manage multiple projects and meet strict deadlines.
- Familiarity with clinical trial processes and medical terminology.
Lead Pharmacovigilance Scientist
Posted 22 days ago
Job Viewed
Job Description
Responsibilities:
- Oversee the collection, assessment, and reporting of adverse event data from various sources.
- Conduct signal detection and risk assessment activities for assigned products.
- Prepare and review Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
- Ensure compliance with global regulatory requirements for pharmacovigilance.
- Collaborate with clinical development, medical affairs, and regulatory affairs teams.
- Contribute to the development and implementation of pharmacovigilance processes and systems.
- Train and mentor junior pharmacovigilance staff.
- Act as a subject matter expert for internal and external stakeholders regarding drug safety.
- Participate in safety data review meetings and contribute to risk-benefit assessments.
- Respond to regulatory agency inquiries related to drug safety.
Qualifications:
- Advanced degree (M.S., Pharm.D., Ph.D.) in a life sciences, pharmacy, or medical field.
- Minimum of 7 years of experience in pharmacovigilance or drug safety.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA).
- Experience with safety databases and reporting systems.
- Strong analytical and critical thinking skills for signal detection and risk assessment.
- Excellent written and verbal communication skills.
- Ability to work effectively in a cross-functional team environment.
- Prior experience in a lead or supervisory role is preferred.
- Understanding of clinical trial processes and pharmaceutical development is beneficial.
This is an excellent opportunity to join a company committed to scientific excellence and patient well-being, with a blend of remote flexibility and office presence in Plymouth, Devon, UK .
Principal Pharmacovigilance Scientist
Posted 22 days ago
Job Viewed
Job Description
Key Responsibilities:
- Lead the safety assessment of assigned pharmaceutical products, including signal detection, evaluation, and risk management planning.
- Author and review aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and DSURs, for regulatory submissions.
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure comprehensive safety surveillance.
- Interpret safety data from clinical trials, post-marketing studies, and spontaneous reports.
- Prepare safety information for Investigator Brochures, Informed Consent Forms, and other clinical trial documents.
- Act as a subject matter expert on pharmacovigilance regulations and guidelines (e.g., FDA, EMA).
- Respond to regulatory authority inquiries regarding product safety.
- Mentor junior scientists and contribute to the development of the pharmacovigilance team.
- Ensure compliance with all applicable pharmacovigilance regulations and company policies.
- Advanced degree (MSc, PhD, PharmD, MD) in a life science, pharmacy, medicine, or related field.
- Minimum of 7-10 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations and guidelines.
- Proven experience in signal detection, risk assessment, and regulatory reporting.
- Strong scientific writing and communication skills, with the ability to clearly articulate complex safety information.
- Experience with safety databases and data analysis tools is essential.
- Excellent analytical and critical thinking abilities.
- Ability to work effectively in a hybrid environment, collaborating with colleagues both in the office and remotely.
- Demonstrated leadership potential and the ability to influence decision-making.
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Principal Pharmacovigilance Scientist
Posted 22 days ago
Job Viewed
Job Description
Key responsibilities include:
- Leading the design and implementation of pharmacovigilance strategies for assigned products.
- Performing signal detection and assessment, including the investigation of potential safety signals from various data sources (e.g., spontaneous reports, clinical trials, literature).
- Preparing and reviewing Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory safety documents.
- Contributing to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
- Collaborating with cross-functional teams, including regulatory affairs, clinical development, medical affairs, and data management, to ensure integrated safety oversight.
- Interpreting complex safety data and providing expert medical and scientific input on product safety profiles.
- Representing the company in safety-related discussions with regulatory authorities and key opinion leaders.
- Mentoring and guiding junior members of the pharmacovigilance team.
- Staying current with global regulatory requirements and industry best practices in pharmacovigilance.
- Contributing to the continuous improvement of pharmacovigilance processes and systems.
Clinical Research Associate
Posted today
Job Viewed
Job Description
Clinical Research Associate (CRA) – Hybrid – London Region
RBW Consulting is excited to announce an opportunity on behalf of a small CRO client we are partnered with. This company focuses on UK-based studies and site visits are regionally based around the London area.
This opportunity offers exposure to varied therapy areas, manageable site visits, and the chance to develop beyond traditional monitoring responsibilities.
The Role
You’ll be working on a broad portfolio of studies, from initiation through to close out, across multiple therapy areas including respiratory and emerging fields. This hybrid position involves monitoring sites (primarily in and around London) and attending the office approximately twice per month.
Key responsibilities include:
- Monitoring visits at UK trial sites
- Setting up, managing, and maintaining eTMFs
- Ensuring delivery of studies within budget and timelines
- Liaising with sponsors, vendors, and internal teams to maintain project oversight
- Supporting colleagues through training and mentoring in areas of expertise
- Contributing to project, client, and team meetings
What We’re Looking For
- At least 1 year experience as a CRA (can consider candidates with academic or industry experience)
- A proactive approach with the flexibility to handle multiple priorities in a dynamic environment
The Offer
- Salary range: £40,000–£47,000 , with potential annual increases
- 25 days annual leave plus standard benefits
- Hybrid working model (office attendance twice per month)
- Opportunities for professional growth, with development into Senior CRA or Project Management roles
This role is ideal for CRAs who enjoy a mix of independence and collaboration, and who want to be part of an organisation that values quality, career growth, and work-life balance.
To apply:
Please click ‘apply’ or contact Joe Pearce for any further information
About RBW Consulting
RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.
We are an equal opportunities Recruitment Business and Agency
RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.
Clinical Research Associate
Posted today
Job Viewed
Job Description
Clinical Research Associate (CRA) – Hybrid – London Region
RBW Consulting is excited to announce an opportunity on behalf of a small CRO client we are partnered with. This company focuses on UK-based studies and site visits are regionally based around the London area.
This opportunity offers exposure to varied therapy areas, manageable site visits, and the chance to develop beyond traditional monitoring responsibilities.
The Role
You’ll be working on a broad portfolio of studies, from initiation through to close out, across multiple therapy areas including respiratory and emerging fields. This hybrid position involves monitoring sites (primarily in and around London) and attending the office approximately twice per month.
Key responsibilities include:
- Monitoring visits at UK trial sites
- Setting up, managing, and maintaining eTMFs
- Ensuring delivery of studies within budget and timelines
- Liaising with sponsors, vendors, and internal teams to maintain project oversight
- Supporting colleagues through training and mentoring in areas of expertise
- Contributing to project, client, and team meetings
What We’re Looking For
- At least 1 year experience as a CRA (can consider candidates with academic or industry experience)
- A proactive approach with the flexibility to handle multiple priorities in a dynamic environment
The Offer
- Salary range: £40,000–£47,000 , with potential annual increases
- 25 days annual leave plus standard benefits
- Hybrid working model (office attendance twice per month)
- Opportunities for professional growth, with development into Senior CRA or Project Management roles
This role is ideal for CRAs who enjoy a mix of independence and collaboration, and who want to be part of an organisation that values quality, career growth, and work-life balance.
To apply:
Please click ‘apply’ or contact Joe Pearce for any further information
About RBW Consulting
RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.
We are an equal opportunities Recruitment Business and Agency
RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.