Global Pharmacovigilance Policy, Regulation and Compliance Manager

13 ago - Italia
Altro

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 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) organizatio

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