Global Pharmacovigilance Policy, Regulation and Compliance Manager

In this GPV PRC Manager role, you support the Global Pharmacovigilance (GPV) organization and the QPPV to maintain and advance the pharmacovigilance system, ensuring compliance and effective communication. You collaborate with cross-functional teams to improve procedures, training, audits, and regulatory requirements, driving efficiency and compliance. You will coordinate data-driven reports, training curricula, and PV-related communications, contributing to global PV governance and risk management. This is an opportunity to shape pharmacovigilance processes in a global, multi-site environment while aligning with Elanco’s mission to Go Beyond for Animals, Customers, Society and Our People.

- Coordinate monthly GPV compliance reports including data extraction, KPI tracking, and trend analysis with cross-functional stakeholders
- Maintain GPV procedures and training activities, including lifecycle management, document authoring/review, and onboarding/offboarding support
- Manage GPV training curricula and assist supervisors with training plans and system modules

- Support nomination and oversight of local pharmacovigilance roles and local PV procedures/quality management
- Coordinate GPV audits and inspections: planning, documentation, coordination, CAPA monitoring
- Oversee pharmacovigilance agreements (PVAs): creation, maintenance, periodic review, monitoring obligations
- Assist in preparation/maintenance of the Pharmacovigilance System Master File (PSMF) content and annexes
- Coordinate xysqume pharmacovigilance communications with external partners/customers per procedures and plans
- Serve as primary contact for cross-functional stakeholders (Quality, regional affiliates) to ensure GMP PV compliance
- Degree or diploma in veterinary science, pharmacy, life sciences, or related is preferred and 2-3 years’ experience in regulated industry

In this GPV PRC Manager role, you support the Global Pharmacovigilance (GPV) organization and the QPPV to maintain and advance the pharmacov…
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Global Pharmacovigilance Policy, Regulation and Compliance Manager

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