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 .