8 Pharmacovigilance Specialists jobs in the United Kingdom

• 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.

• 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.

• 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.

• 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.

Job Description CK Group are recruiting for a Senior Pharmacovigilance Scientist to join a company in the pharmaceutical industry on an outside IR25 contract basis until the end of 2026.

Salary: £40 - £8 per hour UMB / LTD or 9.85 - 5.82 per hour PAYE

Senior Pharmacovigilance Scientist Role:

Use your pharmacovigilance expertise, particularly individual case safety report (ICSR) knowledge, to ensure safety data is processed and reported in a high quality, compliant manner, so it can be used to understand and communicate the product benefit risk to protect patients’ safety.
Performing oversight of service provider who execute ICSR tasks (and Medical Device reports)
Identifying root causes of non-compliance to agree Corrective Actions and Preventative Actions (CAPAs), which you may be responsible for implementing
Effective oversight of service providers via relationship management, and metrics and analysis.
Leadership of complex initiatives with multiple stakeholders, with the ability to investigate and creatively solve problems and simplify, whilst meeting customer needs.

Your Background :

Demonstrated experience in a breadth of areas pertaining to pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly-evolving personalised healthcare environment and ecosystem
Medical Device processing experience, knowledge.
Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
A relevant Life Science degree or equivalent experience in pharmacovigilance.
Strong broad knowledge across end-to-end ICSR processes

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

This role is based at our clients site in Welwyn Garden City (Hybrid role, 2 days per week required on site).

Apply:

For more information, or to apply for this Senior Pharmacovigilance Scientist role, please contact the Key Accounts Team on or email Please quote reference 151 132.

It is essential that applicants hold entitlement to work in the UK

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

INDKA