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Posted: 10/20/2026Senior 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 enhance safety reporting within a GxP-regulated environment.
Highest-signal resume keywords
Pharmacovigilance Operations ManagementGlobal Safety Operations OversightRegulatory Submissions ExperienceSafety Database ProficiencyCross-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, ICSRs, SUSAR reporting, and submissions to global regulatory authorities
- Lead oversight and governance of 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 support regulatory inspections, partner audits, and quality assessments, including CAPA development and implementation
- Monitor KPIs, quality metrics, dashboards, and trend analyses to drive continuous improvement
- Collaborate with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners
- Support aggregate safety reporting, 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, including increasing levels of responsibility
- 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, Individual Case Safety Reports (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, Risk Management Plans, and related regulatory deliverables
- 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 in a related scientific discipline 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 with occasional travel
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 ProcessingIndividual Case Safety Reports (ICSRs)SUSAR ReportingAggregate Safety ReportingPharmacovigilance Regulations KnowledgeProcess OptimizationQuality Metrics MonitoringKPI AnalysisRegulatory ComplianceTeam Leadership
Soft Skills
Stakeholder ManagementCommunication SkillsMentoringCollaborationAdaptability
Tools & Technologies
ArgusArisGSafety DatabasesPharmacovigilance TechnologiesMedDRAWHO Drug DictionariesE2B(R3) Reporting Standards
Certifications & Qualifications
Bachelor's Degree in Life SciencesAdvanced Degree (PharmD, MSN, MPH, MS)
Industry Keywords
BiotechnologyPharmaceutical IndustryGxP-Regulated EnvironmentClinical DevelopmentDrug SafetyRegulatory AuthoritiesCAPA DevelopmentEmerging BiotechnologyHealth Authority InteractionsQuality Assessments