This is a full-time, home-based position in Canada.
WHAT YOU WILL DOYou will provide medical safety expertise, directly and indirectly, to sponsor drugs, devices, and combination products in the post marketing world.
Other key responsibilities:
- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
- Provide training and guidance to the case processing team on medical aspects of case processing.
- Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.
- Undertake any other duties as required
YOU NEED TO BRING...
- MD or DO with at least 4 years of pharmacovigilance experience (clinical trial and post approval experience)
- Comprehensive understanding of US healthcare system
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language skills: English proficient in speaking, writing, and reading.
- Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.
- Knowledge and understanding of regulatory requirements for Clinical Research.
- Knowledge and understanding of ICH-GCP guidelines.
PREFERRED NEED TO BRING:- MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years of experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management.
- Strong understanding of regulatory requirements relating to Pharmacovigilance.
- At least 4 years pharmaceutical industry experience, including and specific to pharmacovigilance (post approval experience, case processing, medical review) and/or clinical research.
- 1 to 2 years of clinical practice experience.
Position is based remote in Canada
This position is not eligible for sponsorship.
Benefits:
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
The application deadline is Aug 2, 2026
