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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