Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal

Eli Lilly and Company

Senior Director of Counsel advising on legal matters related to pharmacovigilance and regulatory issues at Lilly. Collaborates with teams to ensure compliance and support product safety.

Posted 5/15/2026full-timeIndianapolis • 🇺🇸 United StatesSenior💰 $195,000 - $286,000 per yearWebsite

About the role

Key responsibilities & impact

Provide strategic, solutions-oriented legal counsel and pharmacovigilance subject matter expertise in support of Lilly’s broad portfolio of products
Serve as the primary legal partner to the pharmacovigilance operations team, providing day-to-day counseling on case management, safety surveillance, safety contracting, vendor oversight, and post-market safety surveillance studies
Provide legal advice and support to product level safety management teams, including assessment of emerging safety issues
Partner with Regulatory Legal Team and other colleagues on clinical development matters where patient safety considerations intersect
Support AI and automation initiatives across Global Patient Safety and Clinical Development
Provide legal, regulatory, and GxP compliance counsel on PV Quality matters
Maintain strong awareness of evolving pharmacovigilance and clinical development related laws, regulations, and guidance
Influence internal and external customers on priority regulatory policy initiatives

Requirements

What you’ll need

Bachelor’s and JD Degrees
Licensed to practice law in one of the US states
Minimum 5-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company
Qualified applicants must be authorized to work in the United States on a full-time basis
Prior regulatory agency experience
Ability to triage, prioritize and effectively counsel a high volume of inputs from a variety of sources
Highly motivated and collaborative partner with strong interpersonal skills
Excellent judgment and meticulous level of attention to detail
Excellent written and verbal communication skills with an ability to influence others
Proven ability to appropriately handle highly confidential information
Proven dedication to expand knowledge and adapt to a changing, rapid-paced environment
Proven leadership and effectiveness in working with senior leadership
Prior experience advising on pharmacovigilance, drug safety, clinical development, or related regulatory matters
Familiarity with global PV frameworks
Experience advising on AI/automation governance or digital health initiatives

Benefits

Comp & perks

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
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancecase managementsafety surveillancesafety contractingvendor oversightpost-market safety surveillanceregulatory complianceGxP complianceclinical developmentAI/automation governance

Soft Skills

interpersonal skillsjudgmentattention to detailwritten communicationverbal communicationinfluencecollaborationleadershipadaptabilityconfidentiality

Certifications

JD DegreeLicensed to practice law