Freelance Pharmacovigilance (PV) Manager

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