Barrington James
Pharmacovigilance Scientist Freelance
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The role
Working within the drug safety function, you'll take ownership of day-to-day PV deliverables, from individual case management through to aggregate reporting and signal work, helping keep the client's safety operations compliant and inspection-ready during a busy period.
Key Responsibilities
- End-to-end ICSR processing, case intake, triage, data entry, medical assessment support, narrative writing and quality review, within agreed timelines
- Contributing to aggregate safety reports (PSURs/PBRERs, DSURs, addendum reports) and supporting the wider periodic reporting cycle
- Supporting signal detection, evaluation and tracking, and helping maintain safety data quality
- Scientific and medical literature screening for adverse events and safety information
- Expedited and periodic regulatory reporting in line with EU/global requirements
- Maintaining compliance with SOPs, safety agreements (SDEAs) and applicable regulations, and supporting audit and inspection readiness
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What We're Looking For
- Solid pharmacovigilance experience (5+ years) in a pharma, biotech or CRO setting (clinical and/or post-marketing)
- A life-sciences, pharmacy, nursing or related degree (or equivalent experience)
- Hands-on with a validated safety database, [Argus / ARISg / Veeva]
- Strong working knowledge of EU and ICH pharmacovigilance requirements (GVP modules, E2B, expedited/periodic reporting)
- Excellent written English, attention to detail, and the ability to work independently at pace
- Available immediately (or at short notice) to commit to the contract term
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This is a contract position (duration TBC)
EUROPE based candidates ONLY
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