Job Description

Job Overview:

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

Summary of Responsibilities:

Undertake primary medical review of cases, including medical assessment of the case for seriousness, lists/labeling, causality, adverse event coding and narrative review. 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. 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 aggregate medical review and signal detection/analysis activities, as required. Actively engage with writing team to ensure quality and compliance SLAs are met through coaching, mentoring and timely feedback. Contribute to RFPs, case studies and white papers as and when required. Participate in client meetings and communications along with the Project team including Drug Safety Meetings and Signal Analysis Meetings, as required. Establish an excellent working relationship with the client medical team including managers/lead(s), as required. Work closely with pharmacovigilance colleagues (including Subject Matter Experts) to ensure appropriate medical interpretation and consistency are applied to aggregate reviews. 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 #+ or higher Writing / Reading: English at ILR level 4 or higher

Experience (Minimum Required):

At least 3 years of safety experience (case processing, medical review, clinical safety). Knowledge and understanding of regulatory requirements for Clinical Research/ Pharmacovigilance. Knowledge and understanding of ICH-GCP guidelines.

Preferred Qualifications Include:

At least 2 years of practicing medicine in a clinical setting. Aggregate safety experience (including aggregate medical review, signal detection and risk management).

Physical Demands/Work Environment:

Travel Requirements:

Regional. % of the time less than 5%. % of the above that requires overnight stay: 75% of above travel. Travel is primarily to where: Regional for client meetings.

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