Pharmacovigilance (PV) Manager - Contract
Remote EU, 12 month contract
The opportunity
I'm partnered with a biotech client who needs an experienced PV Manager to step into their drug-safety function on an interim basis and run it from day one. This is hands-on operational leadership - keeping the safety machine compliant, audit-ready and moving - with immediate impact and minimal ramp-up expected.
What You'll Be Doing
- Overseeing day-to-day PV operations, including ICSR intake, processing and quality review
- Authoring and managing aggregate safety reports (PSURs / PBRERs / DSURs) and supporting RMPs
- Supporting signal detection and management, and benefit-risk assessment
- Maintaining the PSMF, SOPs and GVP compliance; supporting audit and inspection readiness and CAPA
- Acting as deputy to / supporting the EU-QPPV and managing PV service providers or affiliates
- Overseeing literature surveillance and safety-database quality
What You'll Bring
- Life-sciences, pharmacy, medical or nursing background (or equivalent)
- 7+ years in pharmacovigilance / drug safety, with time at manager or senior level
- Strong working knowledge of EU GVP (ICH / FDA a plus)
- Hands-on experience with a safety database (Argus, ARISg or similar)
- Proven aggregate-reporting delivery
- Available at short notice and comfortable owning the function from the outset
- Right to work in EU
Desirable
- QPPV or deputy-QPPV experience
- Signal management and RMP authoring
- Familiarity with AI / automation tooling in PV (case triage, signal, literature)
- Additional European languages
- CRO, consultancy or multi-affiliate experience
What's On Offer
- Competitive hourly rate
- Remote working
- A 12-month engagement with strong extension potential
- A well-regarded client and a genuinely visible remit
Only applicants based in Europe will be reviewed
#J-18808-Ljbffr
Freelance Pharmacovigilance (PV) Manager employer: Barrington James
Barrington James is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals in Epidemiology and Real-World Evidence. With a strong emphasis on employee growth, we offer tailored development opportunities and the chance to lead impactful projects across diverse therapeutic areas in the dynamic UK/Europe market. Join us to be part of a team that values flexibility, creativity, and meaningful contributions to healthcare advancements.