Medical Director – SERM, Clinical Safety, Pharmacovigilance

Job Description:

  • Lead safety evaluation and benefit-risk assessments for assigned products
  • Support pharmacovigilance and risk management activities across clinical development and marketed products
  • Contribute to regulatory submissions and health authority interactions
  • Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs)
  • Analyze and interpret clinical and safety data to support regulatory and business decisions
  • Participate in cross-functional safety governance and product safety discussions
  • Provide protocol and regulatory support throughout the development lifecycle
  • Escalate significant safety concerns and emerging risks when appropriate

Requirements:

  • MD or equivalent physician qualification
  • Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions
  • Experience responding to Health Authority Requests for Information (RFIs)
  • Strong understanding of benefit-risk assessment and safety evaluation
  • Experience supporting regulatory submissions and regulatory authority interactions
  • Excellent scientific writing and communication skills
  • Proficiency in English is mandatory
  • Ability to work independently in a fast-paced, highly matrixed environment
  • Oncology experience is highly desirable but not required
  • Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies
  • Experience supporting global development programs

Benefits:

  • Potential contract extension
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