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Global Pharmacovigilance Senior Medical Director

Beeline Medicines

Remote
Remote Senior 🇬🇧 English
Pharmacovigilance Signal assessment

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

Questions fréquentes

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Source : ats:greenhouse

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Published 1 month ago

Expires 3 weeks from now

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Beeline Medicines