Clinical Safety Physician, Early Drug Development

Posted 2 years ago

Key responsibilities

  • Evaluate and establish the safety profile of this product in collaboration with the different company experts and/or partner vendors
  • Provide expert safety input to the clinical development program, study documents such as study protocols, informed consent, investigator brochures, Development Safety Update Report
  • Be responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities (ongoing review of safety data)
  • Escalates and presents safety issues at company safety governance bodies
  • Ensure the oversight of medical activities outsourced to our PV vendor
  • Be a member of study teams and work in a collaborative and proactive way in a matrix environment.
  • Participate in IDMC meetings or other safety-related interactions with outside collaborators, and in internal safety task forces
  • Be involved in process optimization initiatives and, where needed, set up new activities

Your profile

  • M.D. diploma with at least 4 years experience as a Safety Physician in clinical safety in early clinical phases of drug development in a global pharmaceutical or global CRO
  • Firsthand experience in oncology drug development is a plus
  • Strong experience and knowledge of international clinical development regulations applicable to drugs
  • Experience with Safety Database
  • Experience and willingness to analyze and manage significant safety issues in clinical development
  • Ability, as a leader, to collaborate with cross-functional teams and facilitate communication and are able to make decisions
  • Able to work independently, to take responsibility for allocated projects/tasks, prioritize activities effectively, and meet multiple deadlines successfully with attention to detail, setting high-performance standards for quality
  • Ability to function effectively in high-stress situations
  • Demonstrate excellent written and verbal communication skills in English
  • Proficient in MS Office (Excel, Word, PowerPoint, Outlook, Teams

Job Features


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