900 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
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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
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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
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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
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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.
Senior Drug Safety Scientist
Posted 1 day ago
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Job Description
Responsibilities:
- Perform comprehensive case processing and medical assessment of adverse event reports, ensuring compliance with regulatory requirements and company procedures.
- Contribute to the preparation and maintenance of periodic safety update reports (PSURs), development safety update reports (DSURs), and risk management plans (RMPs).
- Conduct signal detection and evaluation activities, identifying potential safety concerns and recommending appropriate actions.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, on safety-related matters.
- Interpret safety data and provide expert input into clinical trial protocols, Investigator's Brochures, and informed consent forms.
- Serve as a subject matter expert on drug safety regulations and guidelines in various global markets.
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Participate in regulatory authority inspections and internal audits.
- Mentor and provide guidance to junior safety scientists and case processing personnel.
- Stay current with evolving regulatory landscapes and scientific literature related to drug safety.
Qualifications:
- Medical degree (MD, DO, MBBS) or equivalent healthcare professional qualification (e.g., PhD in a relevant life science field with significant safety experience).
- Minimum of 6 years of direct experience in drug safety and pharmacovigilance within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA guidelines) and reporting requirements.
- Experience with safety databases (e.g., Argus, ARISg) and case processing.
- Proficiency in signal detection and management methodologies.
- Strong medical assessment and analytical skills, with the ability to critically evaluate safety data.
- Excellent written and verbal communication skills, with the ability to present complex information effectively.
- Proven ability to work independently and manage multiple priorities in a remote setting.
- Strong collaboration and interpersonal skills.
- Experience with risk management planning and execution.
Senior Pharmacovigilance Manager
Posted today
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Job Description
Working With Us
Challenging. Meaningful. Life-changing. Those aren’t words usually associated with a job — but this opportunity is anything but ordinary. Here, uniquely interesting work happens every day, across every department. From advancing production processes to pioneering scientific breakthroughs, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.
We recognize the importance of balance and flexibility in the workplace. That’s why we offer a variety of competitive benefits, services, and programs to support employees in achieving their goals — both professionally and personally.
Position Purpose
In this role, you will collaborate with global process leads and process owners within Patient Safety to help develop a quality and compliance framework that ensures processes remain robust and inspection-ready. You will provide oversight of pharmacovigilance (PV) processes through monitoring, analysis, and continuous improvement, ensuring alignment with GVP guidelines, regulatory expectations, and industry best practices.
Responsibilities
Quality & Compliance Oversight
- Develop and execute quality and compliance monitoring activities for Patient Safety processes.
- Ensure a strong and compliant GVP Quality Management System is in place.
Data Collation & Analysis
- Gather and analyse data from multiple stakeholders, identifying trends and system health indicators.
- Provide insights that support proactive risk mitigation and process improvement.
Reporting & Visualization
- Create clear, actionable reports and dashboards for stakeholders.
- Translate complex data into meaningful insights to guide decision-making.
Collaboration & Communication
- Work closely with functional leads, process owners, and senior leaders to drive continuous quality improvement.
- Share findings and reinforce process expectations through regular communication.
Strategy & Process Improvement
- Evaluate effectiveness of quality monitoring programs, recommending updates as needed.
- Partner with stakeholders to enhance processes and overall system efficiency.
Stakeholder Management
- Ensure effective oversight of internal and outsourced PV activities.
- Escalate compliance concerns and coordinate remediation actions when required.
Inspections & Audits
- Support inspection and audit preparation, execution, and follow-up.
- Collaborate with Quality Assurance teams to implement continuous improvements.
Tools & Intelligence
- Define business requirements for compliance-related tools and partner with IT to deliver enhancements.
- Contribute to development of data-driven solutions that provide holistic oversight of PV systems.
Key Competencies
- Critical and strategic thinking, with the ability to evaluate evidence and form sound judgments.
- Strong data management and analysis skills, with an eye for identifying trends and anomalies.
- Effective decision-making using data summaries and clear guidelines.
- Proficiency with digital and visualization tools (e.g., Tableau, Power BI); experience with AI/ML approaches is a plus.
Qualifications & Experience
- Degree in Life Sciences, Pharmacy, Nursing, or a related field.
- 8+ years of pharmaceutical industry experience, including pharmacovigilance, clinical development, drug development, or regulatory affairs.
- Deep knowledge of global PV regulations and compliance requirements.
- Proven ability to analyze complex datasets and translate findings into actionable insights.
- Experience in quality and compliance roles within PV or drug safety.
- Track record of advising senior management on regulatory/compliance matters.
- Ability to navigate complex environments and drive accountability.
Why Join Us?
This is a unique opportunity to play a key role in advancing patient safety and shaping the future of pharmacovigilance. You will work in a dynamic, collaborative environment where your contributions directly impact patients’ lives — while developing your own career in meaningful new ways.
Location: Hybrid role, based in either the wider London area (UK) or in Nordics (Sweden, Norway, Denmark or Finland).