Experteer Overview In this role, you lead regional pharmacovigilance operations to translate global safety strategy into regional execution, ensuring high quality, compliant PV activities across all affiliates. You manage a regional team, drive cross-functional collaboration with GPS, QPPVs, and MQO, and uphold continuity and inspection readiness. You will shape regional safety strategy, improve processes, and represent Lilly in regional governance forums. This is an opportunity to influence patient safety at scale within a global leader in medicines.Compensaciones / Ventajas
- Lead and develop regional pharmacovigilance personnel and ensure onboarding, training, and accreditation
- Provide regional operational direction for PV activities (AE management, reporting, risk management, and PV system maintenance)
- Translate global PV strategy into regional execution plans and ensure compliance with GVP
- Maintain regional PV governance, quality systems, and CAPA processes; drive continuous improvement
- Serve as primary interface between GPS and regional safety personnel; manage regional communications
- Build and maintain external relationships with regulatory bodies, industry groups, and KOLs to support safety obligations
- Oversee QPPV network, ensure post-holders meet regulatory qualifications, and manage back-ups




- Ensure local business agreements and vendor governance align with global standards and regional needs
- Develop business continuity and back-up plans for PV activities across the region
- Support health authority engagement, regulatory responses, PSURs, RMPs, and local risk minimization tools
- Champion a culture of quality and inspection readiness; coordinate inspections and audits
- Ensure local PV content in PSMF and compliance with country annexes across markets
- Lead cross-country risk management deliverables and local implementation of safety measuresResponsabilidades
- Bachelor's degree in pharmacy or related field; or equivalent experience
- Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry
- Strong knowledge of international drug and device safety regulations and quality systems
- Experience leading teams across multiple affiliates or geographies
- Experience building PV capabilities with internal and external partners
- Proven leadership and cross-functional communication skills
- Regulatory agency inspection experience
- Experience managing PV operations across countries with varied regulatory regimes and languages
- If applicable, meeting local QPPV/Responsible Person qualifications and regulatory requirementsRequisitos principales
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📌 Associate Director / Director - Regional Pharmacovigilance Leader (Europe) (Barcelona)
🏢 Eli Lilly
📍 Barcelona