Medical Mgr. PSS

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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