Associate Director, Clinical Drug Safety

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $117k - $189.2k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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

• 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

• 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

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