Global Pharmacovigilance Director — Strategy & Compliance

Regulatory Jobs

Indianapolis (IN)

On-site

USD 164,000 - 240,000

Full time

8 days ago

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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

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

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