Senior Director or Executive Director, International Pharmacovigilance Group Leader

At 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.

The Senior Director / Executive Director (SD/ED) of International Pharmacovigilance (PV) provides strategic leadership and operational oversight of all pharmacovigilance activities across Lilly’s global markets. Reporting to the Leader of GPS Capabilities, this role is accountable for ensuring consistent, compliant, and high‑quality adverse event (AE) intake, processing, local risk management/risk mitigation activities, and regulatory reporting (individual and periodic cases) across the global affiliate network.

The SD/ED of International PV will serve as a key member of the GPS Capabilities leadership team, partnering with Safety Science, Case Management, CPQA, Regulatory Affairs, Legal, Tech@Lilly, and International Business Units to ensure pharmacovigilance excellence, regulatory compliance, and patient safety across all international territories.

• Lead the strategic direction, governance, and operational delivery of pharmacovigilance across all international affiliates, ensuring alignment with Lilly’s global PV strategy and GPS Capabilities priorities.

• Drive the execution of the PV centralization strategy, transitioning affiliate PV personnel from commercial affiliate reporting structures into the Global Patient Safety organization, including change management, stakeholder engagement, and workforce planning.

• Establish and maintain a unified international PV operating model that balances global standardization with region‑specific regulatory requirements and cultural considerations.

• Own the international PV budget, resource allocation, and outsourcing strategy, optimizing the mix of internal FTEs, regional hubs, and third‑party vendors to achieve operational efficiency.

• Ensure oversight along with the corresponding GPS functions (i.e. case management, safety science, etc.) of global metrics for compliant local safety requirements.

• Serve as a key point of contact for international regulatory authority interactions on pharmacovigilance matters, supporting inspections, audits, and regulatory inquiries across all markets.

• Act as the senior GPS escalation point for international pharmacovigilance matters raised by regulatory authorities, and ensure inspection, audit and enquiry responses across the international network are coordinated and consistent. Statutory point‑of‑contact status remains with the Local QPPV / responsible person in each country and with the EU QPPV for EMA and EU‑level matters; this role represents Lilly where an issue spans multiple countries, indicates a systemic weakness, or requires executive accountability

• Partner with the international QPPV network to ensure connectivity on key areas for compliance and support.

• Proactively monitor, manage and communicate evolving pharmacovigilance regulatory requirements across major international markets, translating regulatory intelligence into actionable process change proposals. In addition, ensure monitoring of global process or requirement changes that may impact specific or all global…