Safety Physician

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. Learn more about our EEO & Accommodations request here.