Position: Medical Reviewer (Pharmacovigilance) – Work from Home

Location: Canada

Employment Type: Contract

About the Role:

We are seeking a dedicated Medical Reviewer to join our Pharmacovigilance team. In this role, you will be responsible for the independent medical review of Individual Case Safety Reports (ICSRs) for assigned products, ensuring compliance with regulatory standards and contributing to the overall quality of our safety reporting processes.

Key Responsibilities:

- Independently perform the medical review of ICSR for assigned products.
- Conduct retrospective quality checks of medical reviews for cases processed at CROs.
- Perform line listing reviews of non-responsible events.
- Provide regular guidance and training to medical reviewers at CROs.
- Work closely with Medical Safety, case processing, and submissions teams to ensure timely reporting.
- Assist the Global Lead of Medical Review as needed.
- Pro-actively contribute to improving the medical review quality of ICSRs.




- Present topics for discussion in Global Medical Review meetings.

Experience Requirements:

- A medical doctor with MD degree; an additional degree in Epidemiology or Public Health is a plus.
- Minimum of 3 years of experience in Pharmacovigilance as a safety physician performing medical reviews of ICSRs.
- Experience in reviewing clinical study cases, including SUSAR reports, is required.
- Experience in the medical review of device products is preferred.
- Solid understanding of ICH-GCP guidelines and FDA safety regulations.
- Experience handling Health Authority Inspections and preparing CAPA responses is preferred.
- Experience in preparing medical review-related Standard Operating Procedures (SOPs) and Working Practices (WPs) is preferred.
- Experience in signal management and/or preparation of aggregate reports is a plus.

📌 Medical Reviewer (Canada)
🏢 Soterius
📍 Canada