Description

You will lead pharmacovigilance compliance across Europe, ensuring regulatory obligations are met and patient safety is prioritized. This role combines strategic leadership with operational accountability to safeguard patients and maintain positive benefit-risk profiles for oncology therapies.

Requirements

• Prior experience as EU-QPPV in pharmaceutical industry
• Expert knowledge of global PV regulations (GCP, GVP)
• Strategic thinking and results orientation
• Ability to influence and communicate effectively with cross-functional teams
• Vendor management and vendor oversight experience

Responsibilities

• Oversee EU Pharmacovigilance (PV) system and Quality Management System (QMS)
• Ensure compliance with EU PV legislation and GVP modules
• Establish and maintain the Pharmacovigilance System Master File (PSMF)
• Act as primary contact for EMA and national competent authorities on a 24-hour basis
• Manage regulatory inspections and CAPA processes