Global Pharmacovigilance Senior Medical Director
Beeline Medicines
Job description
About the role
Beeline Medicines is seeking a Global Pharmacovigilance Senior Medical Director to lead drug safety across its immunology and inflammation pipeline, including the lead lupus program. This senior physician-level position provides medical and scientific leadership for benefit‑risk evaluation, signal assessment and safety governance worldwide.
Key responsibilities
- Serve as the senior physician for safety science and pharmacovigilance, setting medical standards for individual case safety reports, aggregate analyses, signal evaluations and benefit‑risk assessments across the I&I portfolio.
- Define strategy and quality standards for medical review and clinical interpretation of safety data from clinical trials, spontaneous reports, literature and real‑world sources.
- Provide medical oversight of the pharmacovigilance vendor’s safety evaluation output to ensure timely, accurate and scientifically rigorous assessments.
- Act as the primary physician representative to Health Authorities, Data Safety Monitoring Boards and external advisory bodies for assigned programs.
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs and Program Leadership to deliver medically sound, strategically aligned safety leadership.
Required profile
- Physician (MD) or equivalent with extensive experience in pharmacovigilance and drug safety.
- Proven senior‑level leadership in benefit‑risk evaluation, signal assessment and safety governance for immunology/inflammation programs.
- Experience interacting with regulatory authorities, DSMBs and external advisory committees.
- Ability to influence cross‑functional teams and drive scientific insight.
Required skills
- Pharmacovigilance
- Benefit‑risk evaluation
- Signal assessment
- Medical review of safety data
- Clinical data interpretation
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Published 1 month ago
Expires 3 weeks from now
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Beeline Medicines