Interim Director of Pharmacovigilance

Interim Director of Pharmacovigilance

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.

• 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.

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.