Global PV Partnership & Operations Director
Core
Strategic leadership of the Sobi PV Partnership & Operations function, ensuring compliance and collaboration between internal teams, co-development partners, and external service providers for pharmacovigilance activities.
Role type
Senior IC Director (Pharmacovigilance Operations & Partnerships)
Builds
Compliant PV operations, partner agreements, and safety data management systems for clinical trials and marketed products.
Domain
Pharmaceutical industry + Pharmacovigilance
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance operations, partner/vendor oversight, team leadership, GVP/GCP compliance, safety data management, audit/inspection readiness, case exchange reconciliation, product-level engagement
Preferred skills
IQVIA Vigilance Platform knowledge, international people management experience
Technologies
IQVIA Vigilance Platform, Sobi PV systems, Osiris Configuration
Responsibilities
Lead the PV Partnership & Operations function and manage the global team; oversee partner collaborations and ensure adherence to Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs); manage case exchange, reconciliation, and quality of safety data; lead development of study-level Safety Management Plans; ensure inspection readiness and manage audit/non-conformance activities; oversee PV system configuration and integration for new products and acquisitions.
Seniority
Director, strategic leadership & team management
