Pharmacovigilance Lead - Istanbul, Türkiye

Biopharma Careers; Fatih; On-site; TRY 500,000 - 800,000; Full time

Job summary

Lilly is seeking a Pharmacovigilance Lead in Istanbul, Türkiye to oversee local pharmacovigilance systems and ensure regulatory compliance across the region. The role interfaces with Global Patient Safety and regulatory affairs to manage safety activities and reporting requirements.

The candidate will work with local affiliates, escalate safety issues, and coordinate training and governance of PV processes to ensure ongoing compliance and patient safety.

Qualifications

• Regulatory knowledge of pharmacovigilance practices.
• Experience interpreting national pharmacovigilance regulations.
• Ability to coordinate with cross‑functional teams.

Responsibilities

• Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance in the region.
• Establish and maintain Lilly's local pharmacovigilance system and quality system.
• Coordinate safety communications between local teams, GPS, and regulatory affairs.
• Provide technical expertise on pharmacovigilance legislation for drugs and devices.
• Lead training on adverse event reporting and monitor compliance metrics.
• Review safety-related business agreements and collaborate with external partners.
• Collaborate with local affiliates and be active in pharmacovigilance industry groups.

Job description

# Pharmacovigilance Lead - Istanbul, TürkiyeISTANBUL, Türkiye FULL\\_TIMENotify me about similar jobsView Full Job & Apply at LillyLilly is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.**Key Responsibilities****General Responsibilities and Regulatory Compliance**Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined by legislation and/or guidelines in the respective country(ies) of the region.Responsible for the establishment and maintenance of Lilly's local pharmacovigilance system, including the performance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practice (GVP) requirements in the region.Understand pharmacovigilance activities (such as adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File).Understand the role of the European Qualified Person for Pharmacovigilance (EU QPPV).Escalate any safety and compliance issues to appropriate local and global management.Act as an interface between Global Patient Safety (GPS) and the aligned affiliate.Responsible for appropriate communications between patient safety locally and other stakeholders, GPS, product complaints, medical and regulatory affairs.Provide technical expertise to the aligned affiliate and GPS with respect to the interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.As necessary, ensure appropriate backup coverage is in place in times of absence or unavailability.Ensure relevant stakeholders are made aware of actions initiated for safety reasons for any Lilly product.Lead, coordinate and organize all necessary training on adverse event reporting to the aligned affiliate as appropriate.Review metrics to monitor quality and compliance activities and implement any corrective and/or preventative actions.Responsible for the review and approval of any local business agreements that require safety and regulatory input (such as business alliances, patient support programs, distribution agreements).Collaborate with external customers and be an active participant of the local pharmacovigilance industry association groups.