Senior Director or Executive Director, International Pharmacovigilance Group Leader

Eli Lilly and Company • Us, IN

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About The Position

The Senior Director or Executive Director of International Pharmacovigilance (PV) provides strategic leadership and operational oversight of pharmacovigilance activities across Lilly’s global markets. Reporting to the Leader of GPS Capabilities, the role is accountable for consistent, compliant, high-quality adverse event intake and processing; local risk management and mitigation; and regulatory reporting across the global affiliate network.

As a member of the GPS Capabilities leadership team, the position partners with Safety Science, Case Management, CPQA, Regulatory Affairs, Legal, Tech@Lilly, and International Business Units to support pharmacovigilance excellence, regulatory compliance, and patient safety across international territories. The role leads the PV centralization strategy, establishes a unified operating model, manages the international PV budget and resourcing, supports regulatory interactions, and develops a geographically distributed international PV organization. Travel is required approximately 20%.

Requirements

• Advanced degree (PharmD, PhD, MD, or equivalent) in life sciences, pharmacology, medicine, or a related discipline.
• At least 10 years of experience in pharmacovigilance, drug safety, or overall drug development in the pharmaceutical or biopharmaceutical industry.
• At least 5 years leading functions directly in pharmacovigilance or closely tied to local affiliate work with global or multi-region scope.
• Experience with global pharmacovigilance regulations, including EU GVP Modules, FDA 21 CFR Part 314/600, ICH E2A–E2F guidelines, PMDA requirements, and major emerging-market regulatory frameworks.
• Experience leading large-scale organizational transformations, including centralization, operating model redesign, and digital modernization.
• Experience managing geographically distributed teams across multiple regions, with demonstrated cultural intelligence and cross-border leadership.
• Experience interacting with international regulatory authorities during inspections and/or safety-related inquiries.
• Experience managing CRO/BPO pharmacovigilance vendor partnerships and outsourced cases.

Nice To Haves

• Exceptional executive communication skills, including the ability to develop and deliver board-level and C-suite presentations and strategic business cases.
• Understanding of safety databases, case management platforms, safety science and surveillance, and emerging AI/automation technologies applied to pharmacovigilance.

Responsibilities

• Lead the strategic direction, governance, and operational delivery of pharmacovigilance across international affiliates, aligned with Lilly’s global PV strategy and GPS Capabilities priorities.
• Drive execution of the PV centralization strategy, including transferring affiliate PV personnel into the Global Patient Safety organization, change management, stakeholder engagement, and workforce planning.
• Establish and maintain an international PV operating model that balances global standardization with local regulatory requirements and cultural considerations.
• Own the international PV budget, resource allocation, and outsourcing strategy, optimizing internal FTEs, regional hubs, and third-party vendors.
• Oversee, with corresponding GPS functions, global metrics for compliant local safety requirements.
• Serve as a key contact for international regulatory authority interactions on PV matters and support inspections, audits, and regulatory inquiries across markets.
• Act as the senior GPS escalation point for international PV matters raised by regulatory authorities and coordinate consistent inspection, audit, and inquiry responses across the international network.
• Represent Lilly when a PV issue spans multiple countries, indicates a systemic weakness, or requires executive accountability; statutory point-of-contact status remains with local QPPVs or responsible persons and the EU QPPV for EMA and EU-level matters.
• Partner with the international QPPV network on compliance and support.
• Monitor, manage, and communicate evolving PV regulatory requirements across major international markets, translating regulatory intelligence into actionable process-change proposals.
• Monitor global process or requirement changes that may affect specific or all global affiliates.
• Lead, mentor, and develop Regional PV Heads and affiliate PV professionals across continents, time zones, and regulatory environments.
• Foster a culture of compliance, scientific rigor, continuous improvement, and patient-centricity.
• Build consistent organizational capability in GVP, PV data analytics, and digital literacy across the international PV workforce.
• Develop succession plans and talent pipelines for critical international PV leadership roles.
• Represent International PV on GPS leadership bodies and cross-functional project teams.
• Partner with International Business Units and affiliate leadership to integrate PV into commercial operations while maintaining functional independence.
• Support or drive GPS-level strategic initiatives related to global PV consistency of deliverables.
• Travel approximately 20%.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree