Senior Global PV Policy, Regulation and Compliance manager, Deputy QPPV (EU)
Munkáltató · Elanco
Egyéb egészségügyi szakember
Jogi szakember
Állatorvos, állatterapeutaTeljesBudapest
The Senior Global PV Policy, Regulation and Compliance manager and deputy QPPV for the EU supports the Global Pharmacovigilance (GPV) organization and the Qualified Person for Pharmacovigilance (QPPV) to maintain and advance the global PV system concerning procedure, training, audit/inspection, PV agreements/contracts, compliance management related tasks, and regulatory requirements and communication.
Feladatok
- Manage GPV procedures, training curricula, and onboarding/offboarding activities
- Support Pharmacovigilance Agreements (PVAs) lifecycle management and compliance oversight
- Coordinate GPV compliance reporting, metrics, and stakeholder communication
- Support GPV audits, inspections, CAPA management, and PSMF maintenance
- Act as a key interface between GPV, Quality, and external partners
- Deputize for the 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
Elvárások
- Degree in Veterinary Medicine and at least 3-years experience in regulated industry, preferably in the area of pharmacovigilance
- Knowledge of the processes and regulatory requirements in Veterinary Pharmacovigilance, particularly for the EU
- Located in the EU
- Good English language skills