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 Nursing.
• Preferrably with 2 years clinical experience
• 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:

• 2 years of Clinical practice experience or 2 years PV experience

Physical Demands/Work Environment:

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

Learn more about our EEO & Accommodations request here.