Associate Director / Director - Regional Pharmacovigilance Leader (META)
lilly · Istanbul
Job description
About the role
Lilly is looking for an Associate Director / Director, Regional Pharmacovigilance Leader (META) in Istanbul. The role provides operational and people leadership across pharmacovigilance activities for the regional hub, turning global pharmacovigilance strategy into consistent execution across the region. It works with other regional PV leaders to share learnings and ensures consistency, quality, compliance and continuous improvement across all affiliates, acting as the main link between regional affiliate safety personnel, Global Patient Safety (GPS), Qualified Persons for Pharmacovigilance (QPPVs) and the Medical Quality Organization (MQO).
Key responsibilities
- Lead, develop and motivate regional pharmacovigilance personnel, recruit and train them, run annual performance evaluations and ensure onboarding, training and accreditation are completed.
- Ensure adequate, qualified pharmacovigilance coverage across the region, including nominated Local QPPV and deputy positions, and notify health authorities of changes.
- Operate and maintain the regional pharmacovigilance system, including quality systems, adverse event management, expedited and periodic reporting, risk management and the Pharmacovigilance System Master File.
- Translate the global pharmacovigilance strategy into a regional execution plan and drive consistent local implementation of global processes.
- Evaluate safety and compliance issues with global management and drive corrective and preventive actions.
- Represent the region in GPS governance, manage the internal regional communication network and act as the main interface between GPS and affiliate safety personnel.
- Build relationships with industry associations, professional bodies and key opinion leaders to gather regulatory intelligence and represent Lilly's position.
- Provide technical advice on pharmacovigilance legislation for drugs and devices, oversee vendor performance against the central vendor governance model, and support business agreements requiring safety and regulatory input.
- Establish and maintain regional business continuity plans, including backup and deputy arrangements for Local QPPV roles.
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Published 8 saat önce
Expires 1 ay sonra
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lilly
Istanbul
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