4 Narrative Review Jobs

You will be providing medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. Your responsibilities will include conducting primary medical review of cases, assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. Daily case data update and documentation, along with feedback in appropriate trackers/tools, will be essential for efficient tracking and workflow management. It will be your responsibility to ensure the quality, compliance, and productivity of all assigned deliverables within the expected SLAs and KPIs. After a tenure of 1 year, you will provide training and guidance to the case processing team on medical aspects of case processing. Additionally, you will perform aggregate and signal analysis activities to support single case processing and maintain a culture of high customer service. Qualifications: - Bachelor's degree in medical science, MD, DO, or equivalent degree. - Relevant experience may be considered in lieu of educational requirements. - Language proficiency in English at ILR level 3+ for speaking and ILR level 4+ for writing/reading. Experience: - Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and procedures. - Understanding of regulatory requirements for Clinical Research. - Familiarity with ICH-GCP guidelines. Preferred Qualifications: - 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment: - Work may be in an office or home-based environment as requested by the line manager. For more information on our Equal Employment Opportunity (EEO) and Accommodations request, please refer to our website.,

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. Provide training and guidance to the case processing team on medical aspects of case processing 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 Performs aggregate medical review and signal detection/analysis activities, as required Enhances existing client relationships whenever possible Creates, maintains and assumes accountability for a culture of high customer service Participates in process improvement activities across Company

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. 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. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. 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 only after a tenure of greater than 1year. Performs aggregate medical review and signal detection/analysis activities, as required. Enhances existing client relationships whenever possible. Creates, maintains, and assumes accountability for a culture of high customer service. Participates in process improvement activities across Company. Qualifications (Minimum Required) Bachelors 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 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. 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 1 year of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / clinical research. 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less

As a Medical Safety Expert, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, including assessing seriousness, listed/labeling, causality, adverse event coding, and narrative review. You will be required to update and document case data daily, provide training and guidance to the case processing team on medical aspects, and ensure all assigned deliverables meet quality, compliance, and productivity standards. Additionally, you will perform secondary medical reviews and retrospective reviews to measure the quality of deliverables, identify error trends, and contribute to process improvement activities. Your role may also involve aggregate medical review and signal detection/analysis activities. It is essential to maintain client relationships, promote a culture of high customer service, and participate in enhancing processes across the company. To qualify for this position, you must hold a Bachelor's degree in medical science, MD, DO, or equivalent. Relevant experience may be considered in lieu of educational requirements. Proficiency in English at ILR level 3+ for speaking and level 4+ for writing/reading is required. You should have a working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, regulatory requirements for Clinical Research, and ICH-GCP guidelines. Preferred qualifications include a good understanding of regulatory requirements related to Pharmacovigilance and up to 2 years of experience in the pharmaceutical industry, particularly in pharmacovigilance or clinical research. Clinical practice experience of 1 to 2 years is also preferred. This role may involve working in an office or home-based environment as requested by the line manager. Your dedication to ensuring high-quality deliverables, maintaining strong client relationships, and contributing to process improvements will be key to your success in this role.,