Description
Fortrea is currently seeking an Associate Medical Manager - MD / DO (Patient Safety Solutions), to interact directly with healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment.
This is a full-time, home-based position in Canada.
You will provide medical safety expertise, directly and indirectly, to sponsor drugs, devices, and combination products in the post marketing world.
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.
Requirements:
- 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 Requirements:
- 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.
The position is based remote in Canada.
This position is not eligible for sponsorship.
Pay Range: $100,000-110,000 CAD.