Global Pharmacovigilance Policy, Regulation and Compliance Manager (Madrid)

Global Pharmacovigilance Policy, Regulation and Compliance Manager (Madrid)

03 ago
|
Elanco
|
Madrid

03 ago

Elanco

Madrid

Experteer Overview
Por favor, asegúrese de leer atentamente los siguientes detalles antes de enviar cualquier solicitud.
In this GPV PRC Manager role, you will support Elanco's General Pharmacovigilance function and the QPPV to uphold and advance the global PV system, covering procedures, training, audits, PV agreements, and regulatory requirements. You will interact with multiple departments to improve compliance, efficiency, and effectiveness. The position focuses on maintaining and enhancing PV processes, documentation, and communications with external partners. You will help drive cross-functional collaboration and continuous improvement within a safety-critical domain.
Compensaciones / Beneficios
• Coordinate monthly GPV compliance reports with data extraction, KPI tracking, and cross-functional collaboration
• Maintain GPV procedures and training lifecycle, including document authoring, review, and onboarding/offboarding support
• Manage GPV training curricula and assist supervisors with training plans and module documentation




• Support nomination processes for local pharmacovigilance roles and oversee local PV procedures and quality management
• Coordinate GPV audits and inspections, including planning, documentation, stakeholder coordination, and CAPA monitoring
• Oversee pharmacovigilance agreements (PVAs) including creation, maintenance, and monitoring contractual obligations
• Support preparation and maintenance of the Pharmacovigilance System Master File xqbhyrx (PSMF) and annex management
• Coordinate pharmacovigilance communications with external partners and customers per procedures and plans
• Act as primary contact for cross-functional stakeholders to ensure global PV compliance
Responsabilidades
• Degree or diploma in veterinary science, pharmacy, life sciences, or related (preferred)
• 2-3 years of experience in a regulated industry
• Good English language skills
Requisitos principales


📌 Global Pharmacovigilance Policy, Regulation and Compliance Manager (Madrid)
🏢 Elanco
📍 Madrid

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