Remote Senior Director, Drug Safety Operations

Eli Lilly and Company; Boston (MA); Remote; USD 161,000 - 260,000; Full time

Job summary

Centessa Pharmaceuticals is seeking a Senior Director, Drug Safety Operations to lead global pharmacovigilance activities across clinical programs. This remote US-based role demands strategic leadership, expert safety data handling, and strong vendor governance.

You will ensure compliance with FDA/EMA/ICH GVP standards, drive KPI-driven improvements, and support inspections while collaborating with safety physicians and cross-functional teams.

Qualifications

• Significant pharmacovigilance operations experience.
• Experience managing global safety operations and ICSR processing.
• Deep knowledge of FDA/EMA/MHRA/ICH GVP guidelines.

Responsibilities

• Lead Drug Safety Operations activities across clinical programs.
• Partner with safety leadership to implement governance and resourcing.
• Oversee ICSR processing, SUSAR reporting, and regulatory submissions.
• Ensure inspection readiness and support regulatory audits.
• Manage vendor relationships and external partners for quality and cost.
• Drive KPIs and continuous improvement in safety operations.

Skills

Pharmacovigilance

Drug Safety Operations

GxP compliance

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Advanced degree (PharmD, MSN, MPH, or MS)

Tools

Argus

ArisG

MedDRA

Job description

Centessa Pharmaceuticals is seeking a Senior Director, Drug Safety Operations to lead global pharmacovigilance activities across clinical programs. This remote US-based role demands strategic leadership, expert safety data handling, and strong vendor governance.

You will ensure compliance with FDA/EMA/ICH GVP standards, drive KPI-driven improvements, and support inspections while collaborating with safety physicians and cross-functional teams.