123 Pharmacovigilance Scientist jobs in the United Kingdom

• 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.

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.

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.

• 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.

• Define and lead scientific strategy for drug discovery programs.
• Design and oversee complex biological and pharmacological experiments.
• Identify and validate novel drug targets and therapeutic hypotheses.
• Guide the development of small molecules and/or biologics candidates.
• Manage and mentor a team of research scientists.
• Foster collaborations with academic institutions and industry partners.
• Stay at the forefront of scientific advancements and implement new technologies.
• Contribute to patent applications and scientific publications.
• Present research findings to senior leadership and external stakeholders.

• PhD in Pharmacology, Molecular Biology, Biochemistry, or a related life science discipline.
• 10+ years of progressive experience in drug discovery and development within the pharmaceutical or biotech industry.
• Proven track record of successfully advancing drug candidates into preclinical and/or clinical development.
• Deep expertise in relevant disease areas and drug discovery methodologies.
• Exceptional leadership, team management, and strategic planning skills.
• Strong understanding of medicinal chemistry, pharmacokinetics, and toxicology.
• Excellent written and verbal communication and presentation skills.
• Ability to thrive in a highly collaborative, remote research environment.