Associate Director, Clinical Drug Safety — Remote

Eli Lilly; United States; Remote; USD 117,000 - 189,000; Full time

Job summary

Lilly is seeking an Associate Director, Clinical Drug Safety to lead pharmacovigilance activities across Centessa’s clinical programs. You will support signal detection, DSUR strategy, and safety governance in a fast-paced development environment with cross‑functional teams and external vendors.

The role emphasizes review of safety data, regulatory submissions, and expert input on safety strategy, with remote work in the US and occasional travel to headquarters in Boston.

Qualifications

• RN, PhD, PharmD, MS or BS in health sciences required.
• 6+ years in drug safety with 3+ years pharmacovigilance compliance.
• In‑depth knowledge of safety signal identification, evaluation, and escalation processes.
• Demonstrated capability in aggregate safety data analysis and ongoing safety surveillance.
• Experience overseeing literature surveillance and regulatory submissions.

Responsibilities

• Lead signal detection and risk‑benefit assessment discussions.
• Oversee DSUR strategy and reporting timelines.
• Provide safety input to protocols, Investigator’s Brochures, and regulatory submissions.
• Serve as the lead drug safety representative on cross‑functional study teams.
• Maintain expert knowledge of global drug safety regulations and best practices.
• Collaborate with clinical development, regulatory, medical writing, and QA partners.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional collaboration

Education

RN, PhD, PharmD, MS, BS degree in health sciences or related field

Job description

Lilly is seeking an Associate Director, Clinical Drug Safety to lead pharmacovigilance activities across Centessa’s clinical programs. You will support signal detection, DSUR strategy, and safety governance in a fast-paced development environment with cross‑functional teams and external vendors.

The role emphasizes review of safety data, regulatory submissions, and expert input on safety strategy, with remote work in the US and occasional travel to headquarters in Boston.