Requirements & Experience:

• Assume legal responsibility as EU QPPV for pharmacovigilance compliance
• Maintain oversight of the companys pharmacovigilance system
• Ensure compliance with EU GVP and regulatory obligations
• Oversee safety reporting, signal management, and risk minimization
• Maintain and approve the Pharmacovigilance System Master File PSMF
• Act as the main contact point with EU regulatory authorities
• Lead pharmacovigilance inspections and audits
• Ensure adequate training and resourcing of PV staff
• Oversee implementation of CAPAs and compliance actions
• Provide strategic guidance on drug safety and regulatory risk