Associate Director – Regional Pharmacovigilance Leader

Eli Lilly and Company

. Provide operational and people leadership across pharmacovigilance activities for the aligned European regional hub .

Posted 10/22/2026full-timeArlington Square • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance operations, regulatory compliance, and quality systems while effectively leading and developing teams across multiple affiliates. Proven ability to translate global strategies into regional execution and manage complex safety reporting processes.

Highest-signal resume keywords

Pharmacovigilance ExperienceRegulatory ComplianceQuality Systems KnowledgeLeadership and Team ManagementCross-Functional Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance OperationsAdverse Event ManagementRisk ManagementRegulatory NotificationsPharmacovigilance LegislationInspection and Audit ReadinessPerformance ManagementContinuous ImprovementData AnalysisPharmacovigilance System Master File

Soft Skills

LeadershipInterpersonal SkillsOrganizational SkillsNegotiation SkillsDecision-Making

Tools & Technologies

Pharmacovigilance SystemQuality Management SystemsVendor Governance ModelBusiness Continuity Planning

Certifications & Qualifications

Local QPPV QualificationPharmacovigilance Certification

Industry Keywords

Pharmaceutical IndustryDrug Safety ReportingRegulatory Agency InspectionHealth Authority NegotiationsMedical Quality Organization

About the role

Key responsibilities & impact

Provide operational and people leadership across pharmacovigilance activities for the aligned European regional hub
Translate global pharmacovigilance strategy into consistent regional execution
Ensure consistency, quality, compliance, and continuous improvement across affiliate pharmacovigilance operations
Lead, recruit, train, develop, and manage regional pharmacovigilance personnel
Ensure onboarding, role-specific training, locally mandated accreditation, performance management, career management, and succession planning
Ensure qualified pharmacovigilance coverage, Local QPPV/responsible person and deputy nominations, and regulatory notifications
Operate and maintain Lilly’s regional pharmacovigilance system across aligned affiliates
Oversee adverse event management, expedited and periodic reporting, risk management, and Pharmacovigilance System Master File activities
Drive consistent implementation of global pharmacovigilance processes for drugs and devices
Monitor quality and compliance metrics, investigate gaps, and drive remediation and CAPAs to closure
Serve as primary interface between Global Patient Safety, affiliate safety personnel, QPPVs, and the Medical Quality Organization
Run the regional QPPV and Local Responsible Person network and maintain its roster
Provide technical expertise on pharmacovigilance legislation and regulations across multiple jurisdictions
Establish regulatory, industry, professional-body, network, and key-opinion-leader relationships
Establish and test regional business continuity and backup arrangements
Oversee vendor performance against the central vendor governance model
Support health-authority negotiations, regulatory responses, PSURs, RMPs, and risk-minimization tools
Coordinate inspection and audit readiness and oversee affiliate inspections, audits, and assessments
Ensure SOPs, global quality systems, regulatory obligations, and GPS policies are implemented across the region
Partner with commercial, medical, regulatory, and marketing teams to integrate safety obligations into affiliate activities

Requirements

What you’ll need

Bachelor's degree (or higher) in pharmacy, a medical degree, life science, or health care/pharmaceutical-related field, or equivalent demonstrated experience
Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry
Expertise in interpreting and applying international regulations related to drug and device safety reporting
Strong knowledge of quality systems
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, accountability, flexibility, and ability to deliver high-quality work on complex problems
Regulatory agency inspection experience
Experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages, and business models
Where applicable, qualification, experience, residency, language, and certification requirements prescribed by relevant national legislation for Local QPPV/responsible person or deputy roles
Excellent written and verbal communication, interpersonal, organizational, and negotiation skills
Professional knowledge of English, including medical terminology
Cross-functional networking and relationship development/management
Decision-making and prioritization
Ability to innovate and drive transformational change
Ability to travel as needed (~20%)

Benefits

Comp & perks

Equal opportunities and workplace accommodation support for individuals with disabilities
Ability to travel as needed (~20%)