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Posted: 10/21/2026Senior Director, Drug Safety Operations
Eli Lilly and CompanyCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Drug Safety Operations, including pharmacovigilance processes, regulatory compliance, and team leadership. Proven ability to optimize operational strategies and manage cross-functional collaborations in a fast-paced biotechnology environment.
Highest-signal resume keywords
Pharmacovigilance Operations ManagementGlobal Regulatory ComplianceSafety Database ProficiencyTeam Leadership and DevelopmentCross-Functional Collaboration
About the role
Key responsibilities & impact- Lead Drug Safety Operations activities and manage assigned team members
- Ensure timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across clinical development programs
- Partner with Drug Safety leadership to implement and enhance operational processes, governance activities, and resourcing plans
- Lead execution of the global Drug Safety Operations strategy, operating model, governance framework, objectives, and resourcing plans
- Oversee case intake, triage, processing, medical coding, quality review, ICSR and SUSAR reporting, and submissions to global regulatory authorities
- Govern pharmacovigilance vendors, CROs, safety database providers, and external partners
- Establish and improve pharmacovigilance processes, SOPs, work instructions, quality systems, and operational controls
- Ensure inspection readiness and lead support for regulatory inspections, partner audits, and quality assessments, including CAPA development and implementation
- Monitor KPIs, quality metrics, dashboards, and trend analyses
- Collaborate with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners
- Support aggregate safety reporting activities including DSURs, PBRERs, Risk Management Plans, and other regulatory deliverables
- Drive process optimization, system enhancements, automation, and scalable solutions
- Build, develop, and mentor a high-performing Drug Safety Operations team
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific discipline
- 10+ years of pharmacovigilance and drug safety operations experience within the biotechnology and/or pharmaceutical industry
- Experience supporting small molecule development programs and/or neuroscience/CNS products within an emerging biotechnology environment strongly preferred
- Demonstrated experience managing global safety operations, including case processing, ICSRs, SUSAR reporting, and regulatory submissions within a GxP-regulated environment
- Strong knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, MHRA, ICH, GVP, and applicable international reporting requirements
- Experience overseeing pharmacovigilance vendors, CROs, and external service providers, including performance management, governance, and compliance oversight
- Hands-on experience with safety databases and pharmacovigilance technologies such as Argus, ArisG, or comparable systems
- Familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards
- Experience supporting clinical-stage development programs and aggregate safety reporting activities such as DSURs, PBRERs, and Risk Management Plans
- Proven ability to lead and develop staff, manage competing priorities, and operate effectively in a fast-paced, evolving biotech environment
- Strong cross-functional collaboration, communication, and stakeholder management skills across geographies and organizational levels
- Experience supporting regulatory inspections, audits, and health authority interactions
- Advanced degree such as PharmD, MSN, MPH, or MS preferred
Benefits
Comp & perks- Company bonus depending partly on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Remote work arrangement
- Occasional travel opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case ProcessingICSR ReportingSUSAR ReportingAggregate Safety ReportingPharmacovigilance Process OptimizationQuality Metrics MonitoringRegulatory SubmissionsGxP ComplianceKPI AnalysisRisk Management Plans
Soft Skills
Stakeholder ManagementCommunication SkillsTeam BuildingMentoringAdaptability
Tools & Technologies
ArgusArisGSafety DatabasesPharmacovigilance TechnologiesMedDRAWHO Drug DictionariesE2B(R3) Reporting Standards
Certifications & Qualifications
Bachelor's Degree in Life SciencesAdvanced Degree (PharmD, MSN, MPH, MS) Preferred
Industry Keywords
Pharmaceutical IndustryBiotechnologyDrug SafetyPharmacovigilanceClinical DevelopmentFDA RegulationsEMA GuidelinesMHRA StandardsICH GuidelinesGVP Compliance