Senior Drug Safety Associate Director — Remote US

Eli Lilly and Company; Boston (MA); Remote; USD 117,000 - 189,000; Full time

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director, Clinical Drug Safety to lead pharmacovigilance activities across its clinical programs. Based remotely in the US with limited travel to Boston, the role will oversee signal detection, DSUR planning, ICSR evaluation, and regulatory submissions, ensuring high-quality safety deliverables.

You will collaborate with cross-functional teams and external vendors to maintain inspection-ready processes,

Qualifications

• RN, PharmD, or equivalent by degree
• 6+ years in drug safety with 3+ years pharmacovigilance compliance
• Experience in signal identification and escalation
• Experience with safety data analysis and DSURs
• Knowledge of global drug safety regulations
• Experience leading cross-functional safety activities

Responsibilities

• Signal detection and management across Drug Safety
• Aggregate reports support including DSURs
• Safety science input to protocols and regulatory submissions
• Lead safety governance and cross-functional study teams
• ICSR review and regulatory reporting oversight
• Ensure compliance with evolving safety regulations

Skills

Pharmacovigilance

Signal detection

DSUR preparation

ICSR evaluation

Regulatory submissions

Cross-functional leadership

Literature surveillance

Safety governance

Data analysis

Global regulations

Education

RN/PhD/PharmD/MS/BS in health sciences

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director, Clinical Drug Safety to lead pharmacovigilance activities across its clinical programs. Based remotely in the US with limited travel to Boston, the role will oversee signal detection, DSUR planning, ICSR evaluation, and regulatory submissions, ensuring high-quality safety deliverables.

You will collaborate with cross-functional teams and external vendors to maintain inspection-ready processes,