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, listedness/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, only after a tenure of 1 year.
- Performs aggregate and signal analysis activities, as required in support of single case processing.
- Creates, maintains, and assumes accountability for a culture of high customer service.
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:
- 1 to 2 years of Clinical practice experience.
Physical Demands/Work Environment:
- Office or home-based environment, as requested by the line manager.
Learn more about our EEO & Accommodations request here.
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