Job Description

Job Overview:

Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.

Summary of 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. Performs aggregate medical review and signal detection/analysis activities, as required. Enhances existing client relationships whenever possible. Creates, maintains, and assumes accountability for a culture of high customer service. Participates in process improvement activities across Company. And all other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelor's degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Language Skills:

Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher.

Experience (Minimum Required):

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 Qualifications Include:

Good understanding of regulatory requirements relating to Pharmacovigilance. Up to 2 years pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or clinical research. 1 to 2 years of clinicial practice experience.

Physical Demands/Work Environment:

Office or home-based environment, as requested by the line manager.

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