The Pharmacovigilance Physician position with PrimeVigilance offers an opportunity for Medical Doctors to start and develop your career in Drug Safety. PrimeVigilance’s Pharmacovigilance Physician team is based in North America, Europe and Asia.

Key Accountabilities

  • Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
    • Review includes coding, assessment of seriousness, expectedness, and causality
    • Writing of Company comment, follow-up questions and analysis of similar events
    • Completion of all required supporting documentation such as trackers
  • Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
  • Review and provide input in periodic reports
  • Review literature screening search strategy and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings

Qualifications

  • MD Qualification
  • Ability to plan, organise, prioritise and execute multiple tasks
  • Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
  • Strong communication and presentation skills
  • Advanced English skills, both verbal and written, at least B2
  • Advanced knowledge of MS Office