Added
13 days ago
Type
Full time
Salary
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clinical research pharmacovigilance drug safety ich-gcp regulatory compliance

๐Ÿ“‹ Description

  • Conduct primary medical reviews of safety cases involving drugs, medical devices, and combination
  • Maintain accurate and up-to-date case information, document feedback, and use designated trackers
  • Take ownership of assigned deliverables, ensuring compliance with established quality standards
  • Provide medical guidance, training, and support to case processing teams to strengthen case
  • Perform secondary medical reviews and retrospective quality reviews as required, evaluating
  • Apply relevant clinical research, pharmacovigilance, and medical safety requirements when reviewing

๐ŸŽฏ Requirements

  • Medical degree (MD or DO) required. Relevant equivalent experience may be considered in lieu of
  • At least 4 years of pharmacovigilance experience, including clinical trial and post-approval
  • Strong knowledge of adverse event assessment, case processing, medical review, drug safety, and
  • Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and clinical
  • Understanding of regulatory requirements for clinical research and pharmacovigilance, including
  • Comprehensive understanding of the US healthcare system.

๐ŸŽ Benefits

  • Competitive Salary: Annual pay range of CAD $100,000-$110,000.
  • Remote Work: Full-time, home-based position within Canada.
  • Professional Impact: Opportunity to apply medical expertise to patient safety and the evaluation of
  • Specialized Experience: Work across post-marketing safety activities and contribute to
  • Collaborative Environment: Partner with case processing professionals and support team development
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