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Global Pharmacovigilance (PV) Compliance & Safety Operations

Job description

6-12 month remote contract (must be residing in EU/UK/Switzerland) 

The Role:

We're seeking a strategic leader to head our Global Pharmacovigilance (PV) Compliance & Safety Operations. This role ensures that the global safety systems for medical devices and combination products meets the highest standards of regulatory compliance, inspection readiness, and operational excellence.
 
Key Responsibilities:
  1. Lead global PV compliance strategy across diverse markets (FDA, EU MDR/IVDR, etc.)
  2. Oversee safety operations, case management, and post-market surveillance
  3. Drive inspection readiness, audits, and continuous QMS improvement
  4. Partner cross-functionally with Regulatory, Clinical, Quality, and R&D
  5. Manage a global team and key vendor partnerships
 
About You:
  1. 10+ years in global PV/safety, including device vigilance and leadership
  2. Deep knowledge of global safety regulations (GVP, MDR, ISO 13485, etc.)
  3. Proven success in audits/inspections and safety system optimization
  4. Strong communicator and collaborator in complex, matrixed settings