Pharmacovigilance Officer (12 -month FTC) - Pharmaceuticals - Coventry
Smart4 Sciences is partnering with a fast-growing pharmaceutical company that develops and commercializes a wide portfolio of branded and generic medicines. They deliver high-quality products while building long-term partnerships across the value chain. We are now recruiting a Pharmacovigilance Officer to play a key role in supporting safety and compliance activities.
The Role
As Pharmacovigilance Officer, you will be responsible for a broad range of PV activities, including processing and training on Individual Case Safety Reports (ICSRs), liaising with regulators, identifying safety trends, and preparing case summaries and causality assessments. You will also review, draft, and approve PV documentation to ensure compliance with global standards.
Key Responsibilities
Monitor, assess, and ensure the safety of medicines by managing adverse event reports.
Collect, review, and process ADRs from healthcare professionals, patients, and literature.
Enter cases into safety databases and ensure timely reporting to regulatory authorities.
Identify potential safety signals and contribute to risk management plans.
Maintain PV documentation systems and support preparation of narratives, case reports, and regulatory filings.
Collaborate with clinical, regulatory, and medical affairs teams.
Liaise with external partners, CROs, and regulatory agencies.
Desirable Skills & Experience
Degree in pharmacy, life sciences, medicine, or related field (advanced qualifications such as MSc/PhD are advantageous).
Knowledge of pharmacovigilance regulations (ICH, GVP, EMA, FDA).
Experience with safety databases (e.g., Argus, ARISg, VigiBase).
Strong analytical and data interpretation skills.
Excellent attention to detail and accuracy in documentation.
Effective communication skills for liaising with regulators and stakeholders.
Ability to work under pressure and meet strict deadlines.
Prior experience in pharmacovigilance, regulatory affairs, or clinical research.
Familiarity with adverse event reporting and case processing.
Why Apply?
Opportunity to work hybrid
Impact on Patient Safety - Play a vital role in protecting public health by monitoring and evaluating adverse drug reactions.
Regulatory & Scientific Expertise - Gain deep knowledge of global regulations while sharpening analytical and scientific skills.
Career Growth & Stability - PV is a rapidly expanding field with strong demand and clear progression opportunities into senior PV, regulatory affairs, or medical affairs roles.
Cross-Functional Exposure - Collaborate with diverse teams across clinical research, regulatory affairs, medical information, and quality assurance.
To apply or find out more, contact for a confidential discussion
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