Description

In this role, you will oversee the pharmacovigilance system to ensure compliance with EU regulations and safeguard patient safety for RAS-addicted cancer therapies. You will act as the primary contact for EMA and national authorities, maintain the PSMF, and lead inspection readiness.

Requirements

• Prior experience as an EU-QPPV
• Expert knowledge of global PV regulations (GCP, GVP)
• Strategic thinking and ability to influence cross-functional teams
• Results orientation and vendor management skills
• Registered with the EMA and listed in PSMF as contact

Responsibilities

• Establish and maintain the Pharmacovigilance (PV) System and ensure its appropriateness and effectiveness
• Ensure all safety information is collected, processed and reported in compliance with EU regulations
• Oversee implementation of GVP requirements across the organization
• Act as legally designated QPPV and ensure compliance with EU PV legislation and national requirements
• Maintain oversight of product safety profiles and manage emerging safety issues