[Hiring] Associate Medical Manager @Fortrea

Role Description

Fortrea is currently seeking an Associate Medical Manager - MD / DO (Patient Safety Solutions), to interact directly with our 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.

• 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.
• Perform 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.

Qualifications

• MD or DO with at least 4 years of pharmacovigilance experience (clinical trial and post approval experience).
• Comprehensive understanding of US healthcare system.
• 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.

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.
• 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.