Pharmacovigilance Lead (Istanbul)

About the role

Lilly is seeking a Pharmacovigilance Lead to oversee its local pharmacovigilance system in Istanbul. The role ensures compliance with national and global safety regulations while supporting patient safety initiatives across the affiliate.

Key responsibilities

• Maintain and improve Lilly’s local pharmacovigilance system, ensuring adherence to Good Vigilance Practice (GVP) and legal requirements.
• Manage adverse event case entry, follow‑up, and timely reporting to Global Patient Safety (GPS).
• Act as the primary interface between GPS, local affiliates, and external stakeholders for safety and regulatory matters.
• Lead training on adverse event reporting and monitor quality metrics, implementing corrective actions as needed.
• Ensure inspection and audit readiness, support development of global SOPs, and oversee compliance with MoH/regulatory authority requirements.

Required profile

• Bachelor’s degree in a health profession (Pharmacy or Medicine) and at least 5 years of drug safety or pharmacovigilance experience.
• Demonstrated knowledge of national and EU pharmacovigilance legislation, GVP, and pharmacovigilance system master file (PSMF) maintenance.
• Prior people‑management experience, with ability to recruit, train, and develop a high‑performing team.
• Excellent written and verbal communication skills in English, including medical terminology.

Required skills

• Adverse event case entry and safety database management.
• Good Vigilance Practice (GVP) implementation.
• Pharmacovigilance System Master File (PSMF) creation and maintenance.
• Regulatory compliance and inspection readiness.