Associate Director – Regional Pharmacovigilance Leader

Eli Lilly and Company

. Lead and develop regional pharmacovigilance personnel through objectives, development plans, training, performance management, career management, and succession planning .

Posted 10/23/2026full-timeIndianapolis • United StatesSenior💰 $124,500 - $182,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance operations, regulatory compliance, and quality systems while effectively leading teams and managing cross-functional communication across multiple jurisdictions. Proficient in developing and executing regional pharmacovigilance strategies and maintaining relationships with health authorities and industry stakeholders.

Highest-signal resume keywords

Pharmacovigilance ExperienceRegulatory Agency Inspection ExperienceLeadership and Team ManagementQuality Systems KnowledgeCross-Functional Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance OperationsAdverse-Event ManagementRisk ManagementPharmacovigilance System Master FilePeriodic ReportingLocal QPPV ResponsibilitiesRegulatory ComplianceInspection ReadinessDrug Safety-Reporting RegulationsCAPA Management

Soft Skills

LeadershipInterpersonal SkillsOrganizational SkillsNegotiation SkillsFlexibility

Industry Keywords

Pharmaceutical IndustryHealth AuthoritiesPharmacovigilance NetworksMedical Quality OrganizationLocal Risk-Minimization ToolsPSURsRMPsVendor Governance ModelSuccession PlanningTraining and Development

About the role

Key responsibilities & impact

Lead and develop regional pharmacovigilance personnel through objectives, development plans, training, performance management, career management, and succession planning
Ensure qualified pharmacovigilance coverage, Local QPPV/responsible-person and deputy nominations, onboarding, accreditation, and inspection-ready records across assigned countries
Translate global pharmacovigilance strategy into regional execution plans and maintain Lilly's regional pharmacovigilance system
Oversee adverse-event management, expedited and periodic reporting, risk management, Pharmacovigilance System Master File activities, and licensed-partner obligations
Drive consistent local implementation of global pharmacovigilance processes for drugs and devices
Monitor quality and compliance metrics, investigate gaps, drive remediation and CAPAs, and report systemic issues to global functions
Serve as primary interface between Global Patient Safety, affiliate safety personnel, QPPVs, and the Medical Quality Organization
Lead regional communication networks and QPPV/Local Responsible Person forums
Maintain relationships with health authorities, industry associations, professional bodies, pharmacovigilance networks, and key opinion leaders
Provide technical expertise on pharmacovigilance legislation and regulations across multiple jurisdictions
Establish business continuity, backup, deputy, vendor, system, and alliance-partner arrangements
Support health-authority negotiations, regulatory responses, PSURs, RMPs, and local risk-minimization tools
Oversee vendors and service providers under the centrally owned vendor governance model
Coordinate inspections, audits, assessments, SOP implementation, quality systems, and inspection readiness
Partner with commercial, medical, regulatory, marketing, legal, quality, and global safety teams
Act in accordance with privacy policies and related procedures

Requirements

What you’ll need

Bachelor's degree or higher in pharmacy, medicine, life science, health care, or a pharmaceutical-related field, or equivalent demonstrated experience
Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry
Experience supervising, managing, and leading teams across multiple affiliates or geographies
Experience building pharmacovigilance capabilities internally and externally with partners
Strong leadership, cross-functional communication, flexibility, accountability, and ability to deliver high-quality work on complex problems
Regulatory agency inspection experience
Must meet applicable qualification, experience, residency, language, and certification requirements when serving as a Local QPPV/responsible person or deputy
Excellent written and verbal communication, interpersonal, organizational, and negotiation skills
Professional knowledge of English, including medical terminology
Expertise interpreting and applying international drug and device safety-reporting regulations
Strong knowledge of quality systems
Experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages, and business models
Ability to travel as needed, approximately 20%
Experience holding, deputizing for, or directly overseeing a Local QPPV or nationally designated responsible-person position is preferred/additional

Benefits

Comp & perks

Company bonus depending partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities
Equal opportunity workplace and disability accommodation support