Associate Medical Manager I

Job description

Job Overview: Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the postmarketing period; and may manage a team. 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. • 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. • Undertake and complete additional tasks/activities, assigned by supervisor, as required • Provide training and guidance to the case processing team on medical aspects of case processing. • Undertake primary medical review of aggregate safety reports (PSURs, PADERs, PBRERs). • Participate in ongoing safety surveillance and signal detection/analysis activities including aggregate data review /trend analysis. • Facilitate and Participate in Drug Safety Meetings and Signal Analysis Meets, as required. • Evaluate, interpret, synthesize, and critically discuss safety data. • Establish an excellent working relationship with the client medical team including Managers/leads as required. • Actively engage with the writing team to ensure quality and compliance SLAs being met through coaching, mentoring and timely feedback. • Responsible to impart training to resources as needed. • Should perform medical triage activity. • 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. 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 3 years of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / clinical research. • 1- 2 years of Clinical practice experience preferred. Learn more about our EEO & Accommodations request here .