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Associate Director, Clinical Drug Safety
Eli Lilly and Company. Support pharmacovigilance activities across Centessa’s clinical-stage development programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and drug safety, with a strong focus on safety signal identification, regulatory compliance, and aggregate safety data analysis. Proven ability to collaborate effectively with cross-functional teams and provide scientific oversight in drug safety activities.
Highest-signal resume keywords
Pharmacovigilance Compliance ExperienceAggregate Safety Data AnalysisDSUR Preparation and ReviewGlobal Drug Safety Regulations KnowledgeSignal Identification and Management
ATS Keywords
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Hard Skills
Safety Signal IdentificationAggregate Safety Data AnalysisRisk–Benefit AssessmentMedical Literature SurveillanceDSUR PreparationRegulatory SubmissionsICSR AssessmentSAE EvaluationCausality AssessmentGovernance Frameworks
Soft Skills
Strong Analytical SkillsAttention to DetailClear CommunicationTeam Collaboration
Certifications & Qualifications
RNPhDPharmDMSBS Degree in Health Sciences
Industry Keywords
BiotechPharmaceuticalDrug SafetyPharmacovigilanceClinical DevelopmentRegulatory ComplianceSafety GovernanceSUSAR PreparationCNS Experience
About the role
Key responsibilities & impact- Support pharmacovigilance activities across Centessa’s clinical-stage development programs
- Review and analyze safety data for ongoing safety surveillance, signal management, regulatory compliance, and program execution
- Support overseeing aggregate reports production and literature review
- Implement signal identification and management strategy with Drug Safety and cross-functional partners
- Analyze aggregate safety data, identify emerging safety signals, and contribute to risk–benefit assessments
- Review adverse event and other safety-related data for signal detection
- Oversee literature surveillance and communicate clinically relevant findings
- Coordinate signal review activities and prepare safety governance slides and meeting minutes
- Provide scientific input into DSURs, line listings, and other aggregate reports
- Oversee DSUR strategy, preparation, and timelines with cross-functional partners and vendors
- Provide scientific input into safety sections of protocols, Investigator’s Brochures, and regulatory submissions
- Serve as lead drug safety representative on cross-functional study teams
- Shape safety strategy, influence program decision-making, and advise on safety issue management
- Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners
- Review complex cases and contribute to regulatory-ready case narratives and submissions, including SUSARs
- Oversee vendor-led ICSR and clinical trial SAE evaluations
- Lead or contribute to cross-functional safety projects, signal evaluations, and ad hoc scientific analyses
- Ensure drug safety activities remain compliant with evolving regulations
- Support implementation, execution, maintenance, and improvement of safety processes
Requirements
What you’ll need- RN, PhD, PharmD, MS, BS degree in health sciences or related field required
- 6+ years of experience in drug safety in the biotech/pharmaceutical industry
- 3+ years of pharmacovigilance compliance experience
- In-depth knowledge of safety signal identification, evaluation, and escalation processes, including governance frameworks and contribution to labeling updates
- Capability in aggregate safety data analysis, ongoing safety surveillance, and risk–benefit assessment for investigational products
- Experience overseeing and interpreting medical literature surveillance
- Expertise in scientific review and preparation of DSURs, line listings, aggregate safety summaries, Investigator’s Brochures, protocols, and regulatory submissions
- Advanced knowledge of global drug safety/pharmacovigilance regulations, guidelines, and best practices
- Scientific expertise in ICSR and clinical trial SAE assessment, including causality, seriousness, expectedness, and regulatory reportability
- Experience guiding SUSAR preparation
- Ability to provide scientific and quality oversight of vendor-led safety activities
- Technical proficiency serving as a drug safety subject matter expert on cross-functional teams
- Advanced Degree (PharmD, PhD strongly preferred)
- CNS experience preferred
- Strong analytical skills and attention to detail
- Clear communication and ability to work effectively in small, cross-functional teams
Benefits
Comp & perks- Company bonus depending, in part, 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
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities