Barrington James
Interim Director of Pharmacovigilance
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Contract type: Interim (8 months, with possible extension)
Engagement: Full-time
Location: Remote (Applicants from within Europe only)
Reports to: VP Pharmacovigilance
Start: Immediate / ASAP
Role purpose
To provide senior leadership and continuity to the pharmacovigilance function during a period of transition, growth or resourcing gap. The Interim Director will take operational ownership of the PV system, ensure ongoing regulatory compliance across all markets, and maintain inspection readiness while a permanent appointment is made or a specific programme of work is delivered.
Key Responsibilities
- Provide day-to-day leadership of the global PV function, overseeing case processing, aggregate reporting, signal management and risk management activities.
- Ensure the pharmacovigilance system remains compliant with EU GVP, ICH, FDA and applicable local requirements across all territories.
- Maintain and oversee the Pharmacovigilance System Master File (PSMF), ensuring it remains accurate and inspection-ready.
- Support or deputise for the QPPV as required, and oversee the local safety officer / LPPV network.
- Oversee timely preparation and submission of aggregate reports (PSURs/PBRERs, DSURs, PADERs) and risk management plans.
- Manage safety data exchange agreements (SDEAs) and PV oversight of licensing, distribution and vendor partners.
- Lead or support inspection and audit readiness, including CAPA development and closure.
- Provide medical and strategic input to cross-functional teams (regulatory, clinical, medical affairs, commercial).
- Line-manage and mentor the existing PV team, ensuring stability and knowledge continuity during the interim period.
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Essential experience and qualifications
- Life sciences degree; medical or pharmacy qualification advantageous (MD preferred).
- Substantial pharmacovigilance experience, including leadership of a PV function in a pharma, biotech or CRO setting.
- Deep working knowledge of EU GVP modules, ICH E2 guidelines and global PV regulatory requirements.
- Proven experience of regulatory authority inspections and audits, with demonstrable successful outcomes.
- Strong track record across both clinical-stage and post-marketing safety.
- Ability to step in quickly, operate autonomously and stabilise a function with minimal onboarding.
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Desirable
- Current or previous EU/UK QPPV designation (or deputy QPPV experience).
- Experience of PV system set-up, integration or transformation (e.g. post-acquisition, launch readiness, database migration).
- Experience managing outsourced/partner PV arrangements and affiliate networks.
- Familiarity with safety database systems (e.g. Argus, ArisGlobal) and signal detection tools.
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