Senior Director or Executive Director, International Pharmacovigilance Group Leader

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.

Responsibilities

Lead the strategic direction, governance, and operational delivery of pharmacovigilance across all international affiliates; Drive the execution of the PV centralization strategy, including change management, stakeholder engagement, and workforce planning; Establish and maintain a unified international PV operating model; Own the international PV budget, resource allocation, and outsourcing strategy; Ensure oversight of global metrics for compliant local safety requirements; Serve as a key point of contact for international regulatory authority interactions on pharmacovigilance matters; Act as the senior GPS escalation point for international pharmacovigilance matters raised by regulatory authorities; Partner with the international QPPV network; Monitor, manage and communicate evolving pharmacovigilance regulatory requirements across major international markets; Lead, mentor, and develop a diverse global team of Regional PV Heads and affiliate PV professionals; Foster a culture of compliance, scientific rigor, continuous improvement, and patient-centricity; Build organizational capability in GVP, PV data analytics, and digital literacy; Develop succession plans and talent pipelines for critical international PV leadership roles; Represent the International PV function on GPS leadership bodies and cross-functional project teams; Partner with International Business Units and affiliate leadership to ensure PV integration into commercial operations

Requirements

Advanced degree (PharmD, PhD, MD, or equivalent) in life sciences, pharmacology, medicine, or related discipline; Minimum 10 years of experience in pharmacovigilance, drug safety, or overall drug development within the pharmaceutical or biopharmaceutical industry, including 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; Travel required (~20%)

Nice to have

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

Benefits

Company bonus (depending, in part, on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; Medical, dental, vision and prescription drug benefits; Flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)