Freelance Pharmacovigilance (PV) Manager

Barrington James; Greater London; Remote; GBP 83,000 - 131,000; Full time

Benefits offered by this job

Competitive hourly rate

Remote working

12-month engagement

Strong extension potential

Job summary

Barrington James is partnering with a biotech client to hire an interim PV Manager to lead the drug-safety function from day one. The role is hands-on, ensuring compliance, audit readiness and a smooth operation across ICSR intake, processing and reporting.

The incumbent will manage PSURs/ PBRERs/ DSURs, support signal detection, and maintain PSMF and SOPs, while serving as deputy to the EU-QPPV and coordinating PV service providers. Remote working in Europe is offered for a 12-month engagement.

Qualifications

• Experience leading pharmacovigilance operations in drug safety.
• Strong knowledge of EU GVP and regulatory expectations.
• Hands-on experience with safety databases (Argus/ARISg).

Responsibilities

• Oversee day-to-day PV operations and ICSR intake/processing.
• Author and manage aggregate reports (PSURs/PBRERs/DSURs).
• Support signal detection, benefit-risk assessment and literature surveillance.
• Maintain PSMF, SOPs, and audit/inspection readiness; support CAPA.
• Act as deputy to EU-QPPV and manage PV service providers.

Skills

Leadership

Regulatory compliance

Cross-functional collaboration

Icsr processing

Audit readiness

Education

Life-sciences background

Tools

Argus

ARISg

Job description

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