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.
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