Global PV Partnership & Operations Director

About the role

The PV Partnership & Operations Director provides strategic leadership for Sobi's global pharmacovigilance (PV) partnership and operations function, ensuring effective collaboration with internal teams, co‑development partners, distributors and external service providers.

Key responsibilities

• Lead the PV Partnership & Operations team, set strategic direction, governance, performance expectations and ensure inspection readiness.
• Manage partner‑related PV activities, including implementation and compliance with pharmacovigilance agreements, case exchange, and reconciliation.
• Oversee safety data management for clinical studies and marketed products, coordinating with Clinical Operations, Regulatory Affairs and CROs.
• Ensure quality, compliance and risk management across all PV partnership activities, handling audits, inspections and corrective actions.
• Drive system configuration and operational readiness for new or changed PV partnerships, supporting product integrations and acquisitions.

Required profile

• University‑level qualification in biosciences or related field.
• Extensive experience in global pharmacovigilance, partner management and vendor oversight.
• Proven leadership of cross‑functional, multi‑country teams.
• Strong understanding of GVP, GCP and regulatory inspection requirements.

Required skills

• Pharmacovigilance (PV) processes and agreements
• Good Pharmacovigilance Practice (GVP)
• Good Clinical Practice (GCP)
• Case exchange and safety data reconciliation
• Vendor management and PV system configuration