Senior Director or Executive Director, International Pharmacovigilance Group Leader

Regulatory Toolkit; Indianapolis (IN); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Pension

Health benefits

Well-being programs

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a Senior Director/Executive Director of International Pharmacovigilance. The role leads strategic PV across global markets, oversees centralized operations, and ensures compliance with international regulations and safety reporting.

Travel ~20% and a focus on building a capable international PV team are key aspects. Reporting to GPS Capabilities leadership, you will partner with Safety Science, Regulatory Affairs, and Legal to advance

Qualifications

• Advanced degree in life sciences, pharmacology, medicine, or related discipline is required.
• Minimum 10 years in pharmacovigilance, drug safety, or drug development with 5+ years in leadership.
• Experience with global pharmacovigilance regs (EU GVP, FDA parts 314/600, ICH E2A‑E2F) and emerging markets.

Responsibilities

• Lead strategic direction and governance of pharmacovigilance across international affiliates.
• Drive PV centralization, workforce planning, and global operating model implementation.
• Ensure regulatory compliance and reporting across markets with oversight of regulatory interactions.
• Lead and develop a diverse global PV team across continents and time zones.
• Partner with cross-functional teams to ensure PV aligns with business goals and regulatory requirements.

Skills

PV leadership

Cross-functional collaboration

Executive communication

Global regulatory knowledge

Travel readiness

Education

PharmD/PhD/MD or equivalent

Tools

Safety databases

Case management platforms

Job description

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.

PURPOSE

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.

KEY RESPONSIBILITIES

Strategic PV Leadership & Centralization

• 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.

Regulatory Compliance & Reporting

• 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 affiliates.

Organizational Leadership & Talent Development

• Lead, mentor, and develop a diverse global team of Regional PV Heads and affiliate PV professionals across multiple continents, time zones, and regulatory environments.

• Foster a culture of compliance, scientific rigor, continuous improvement, and patient‑centricity within the international PV organization.

• Build organizational consistent capability with depth 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, ensuring organizational resilience and continuity.

Cross‑Functional Partnership & Governance

• Represent the International PV function on GPS leadership bodies, and cross‑functional project teams.

• Partner closely with the International Business Units, and affiliate leadership to ensure PV integration into commercial operations while maintaining functional independence.

• Support or drive GPS‑level strategic initiatives as it pertains to global PV consistency of deliverables.

QUALIFICATIONS

Required

• 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%)

Additional Qualifications

• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$163,500 - $239,800

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for 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; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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