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.
Learn more about our EEO & Accommodations request here.