Global Pharmacovigilance Medical Director

The role

The Pharmacovigilance Medical Director provides medical and scientific leadership for pharmacovigilance activities supporting the immunology and inflammation pipeline. This role serves as the primary physician voice for benefit-risk evaluation, signal assessment, and safety governance.

What you will do

• Serve as the senior medical expert and physician for safety science and pharmacovigilance activities.
• Lead medical review and clinical data interpretation of safety data from clinical trials, spontaneous reports, literature, and real-world sources.
• Direct the development and maintenance of the company's benefit-risk framework.
• Lead discussion at the company's Safety surveillance governance.
• Oversee the medical content and scientific quality of all aggregate safety reports and regulatory submission dossiers.
• Partner with Clinical Development on medical oversight of DSMB activities and clinical trial safety monitoring plans.
• Provide expert medical input to Risk management plans and regulatory documents.
• Provide medical leadership and scientific mentorship to the Pharmacovigilance team.
• Perform other duties and responsibilities as assigned.

Required qualifications

• Medical degree (MD or DO)
• Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience
• Demonstrated expertise serving as a physician-of-record for pharmacovigilance programs
• Deep knowledge of global safety and pharmacovigilance regulations including FDA guidance, EU GVP Modules I–XVI and ICH guidelines
• Extensive experience providing medical leadership for safety surveillance plan, benefit-risk assessment, and submissions for IND and NDA/BLA
• Proven experience engaging with global Health Authorities on pharmacovigilance topics
• Demonstrated ability to lead or participate in DSMB oversight, clinical trial safety monitoring, and safety governance committee activities at the sponsor level
• Experience contributing to Risk Management Plans (RMPs) and REMS programs
• Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment
• Proven track record of influencing without authority across organizational boundaries
• Exceptional written and verbal communication skills

Nice to have

• board certification or eligibility in immunology, rheumatology, internal medicine, or a relevant specialty experience in autoimmune disease
• at least 2-3 years of dedicated pharmacovigilance or drug safety experience preferred

Benefits

• Competitive health and wellness coverage
• Paid time off, public holidays, and additional leave entitlements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.