Assoc Medical Mgr PSS / PV REMOTE based in Canada

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.

WHAT YOU WILL DO

You 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.

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