The Senior Global PV Policy, Regulation and Compliance manager and deputy QPPV (EU) supports the Global Pharmacovigilance (GPV) organization and the QPPV to maintain and advance the global PV system concerning procedure, training, audit/inspection, PV agreements/contracts, compliance management tasks, regulatory requirements (e.g., PSMF), and communication. Deputizes for the EU/UK QPPV in their absence.
Responsibilities:
- Manage GPV procedures, training curricula, and onboarding/offboarding activities
- Support PV agreements (PVA) lifecycle management and compliance oversight
- Coordinate GPV compliance reporting, metrics, and stakeholder communication
- Support GPV audits, inspections, CAPA management, and PSMF maintenance
- Act as key interface between GPV, Quality, and external partners
- Deputy for EU/UK QPPV when required, including regulatory authority interactions and PV oversight
- Provide strategic PV guidance and support benefit-risk monitoring activities
- Contribute to continuous improvement and compliance initiatives across Global Pharmacovigilance
Minimum qualifications:
- Degree in Veterinary Medicine and at least 3 yearsβ experience in regulated industry, preferably pharmacovigilance
- Knowledge of veterinary pharmacovigilance processes and EU regulatory requirements
- Located in the EU
- Good English language skills
Preferred qualifications:
- Independently make decisions; compliant with strong quality mindset under pressure and short timelines
- Coordinate/lead complex compliance projects
- Experience interacting with EU competent authorities; participating in audits/authority inspections and follow-up
- Effective teamwork in a multicultural environment
- Ability to understand interrelations and propose solutions; personal accountability and strong execution drive