Remote Senior Director, Drug Safety Operations

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

Benefits offered by this job

Company bonus

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Job summary

Eli Lilly and Company is seeking a Senior Director, Drug Safety Operations, to lead global pharmacovigilance activities from a remote US location. You will drive governance, process excellence, and vendor oversight across a dynamic development portfolio.

The role requires extensive experience in safety operations, regulatory submissions, and cross-functional collaboration to ensure patient safety and inspection readiness in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field with strong pharmacovigilance knowledge.
• Advanced degree preferred (PharmD/MPH/MS) and regulatory-inspection experience is a plus.
• Experience leading global safety operations with end‑to‑end case processing and regulatory submissions.
• Proven ability to manage vendors/CROs and ensure compliance and performance.
• Strong knowledge of safety data systems (Argus/ArisG) and coding standards (MedDRA).

Responsibilities

• Lead Drug Safety Operations activities and manage a team to ensure timely safety data collection and reporting.
• Partner with Drug Safety leadership to implement governance, resourcing, and process improvements.
• Oversee pharmacovigilance operations, ICSR processing, SUSAR reporting, and regulatory submissions.
• Manage safety database vendors and external partners to ensure quality and compliance.
• Ensure inspection readiness and support regulatory inspections and audits.
• Monitor KPIs and quality metrics to drive continuous improvement in safety operations.
• Collaborate across functions to align pharmacovigilance with program and corporate goals.

Skills

Pharmacovigilance leadership

Cross-functional collaboration

Global safety operations

Vendor & CRO governance

Regulatory inspections knowledge

Safety data systems (Argus/ArisG)

Education

Advanced degree (PharmD/MPH/MS)

Bachelor’s degree in Life Sciences

Tools

Argus

ArisG

MedDRA

E2B(R3) reporting

Job description

Eli Lilly and Company is seeking a Senior Director, Drug Safety Operations, to lead global pharmacovigilance activities from a remote US location. You will drive governance, process excellence, and vendor oversight across a dynamic development portfolio.

The role requires extensive experience in safety operations, regulatory submissions, and cross-functional collaboration to ensure patient safety and inspection readiness in a fast-paced biotech environment.