Remote Senior Drug Safety Lead (Clinical Safety)

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

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision benefits

Well-being programs

Job summary

Lilly is seeking a remote-based Senior Drug Safety Scientist in the US with extensive pharmacovigilance experience. You will lead signal detection, oversee DSURs and literature surveillance, and collaborate across clinical development, regulatory, and QA to ensure safety governance and regulatory compliance.

Role involves cross‑functional study team collaboration, expert ICSR review, and strategic input on safety sections of regulatory submissions.

Qualifications

• RN/PhD/PharmD/MS/BS in health sciences or related field required.
• 6+ years in drug safety in biotech/pharma with 3+ years pharmacovigilance compliance.
• Experience with safety signal evaluation, governance and labeling updates.
• Strong capability in safety data analysis and risk–benefit assessment.

Responsibilities

• Signal detection and management within Drug Safety and cross‑functional teams.
• Analyze aggregate safety data; identify emerging signals; support risk‑benefit assessments.
• Review adverse event data for signal detection; oversee literature surveillance.
• Coordinate DSURs, line listings, safety summaries; ensure timely governance reviews.
• Provide scientific input for protocols, ICH reports, and regulatory submissions.
• Lead cross‑functional safety projects; mentor vendor safety activities; ensure compliance.

Skills

Signal detection

Literature surveillance

DSUR preparation

Aggregate safety data

Regulatory submissions

Education

Health sciences degree

Job description

Lilly is seeking a remote-based Senior Drug Safety Scientist in the US with extensive pharmacovigilance experience. You will lead signal detection, oversee DSURs and literature surveillance, and collaborate across clinical development, regulatory, and QA to ensure safety governance and regulatory compliance.

Role involves cross‑functional study team collaboration, expert ICSR review, and strategic input on safety sections of regulatory submissions.