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Medical Safety Physician, Pharmacovigilance

Verastem Oncology · Boston et périphérie

🇬🇧 English
MedDRA

Job description

About the role

The Medical Safety Physician will lead pharmacovigilance activities for Verastem Oncology's oncology products. You will provide medical oversight for safety surveillance, signal detection, risk assessment, and regulatory submissions.

Key responsibilities

  • Lead safety surveillance and signal management for assigned products.
  • Provide medical expertise for signal detection, validation, and risk management.
  • Review and assess Individual Case Safety Reports (ICSRs) for investigational and marketed products.
  • Conduct medical review of aggregate safety reports such as PSURs, PBRERs, DSURs, and Annual Safety Reports.
  • Guide adverse event coding (MedDRA) and drug coding (WHO Drug) for clinical trial and post‑marketing data.
  • Evaluate product quality complaints and perform health hazard assessments.
  • Contribute to Risk Management Plans, REMS, and related documentation.
  • Support continuous improvement of pharmacovigilance SOPs and work instructions.

Required profile

  • Medical degree with board certification or equivalent experience in drug safety.
  • Extensive experience in pharmacovigilance for oncology products.
  • Strong knowledge of regulatory requirements for safety reporting.
  • Ability to communicate complex safety information to cross‑functional teams.

Required skills

  • MedDRA coding
  • WHO Drug coding

What we offer

  • Opportunity to work on innovative oncology therapies.
  • Collaborative environment focused on patient safety.
  • Commitment to diversity, inclusion, and professional development.

Questions fréquentes

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Published 3 months ago

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Verastem Oncology

Boston et périphérie