Job
Description
As a Medical Safety Expert, your role will involve providing medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. Your responsibilities will include: - Undertaking primary medical review of cases, including assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. - Updating and documenting daily case data and feedback in appropriate trackers/tools to ensure efficient tracking and workflow management. - Taking complete responsibility for assigned deliverables while maintaining expected quality, compliance, and productivity SLAs and KPIs. - Providing training and guidance to the case processing team on medical aspects of case processing after a tenure of 1 year. - Performing secondary medical review (QC role) and retrospective review of cases (QA role) to measure quality, identify error trends, training needs, and areas of improvement after a tenure of more than 1 year. - Conducting aggregate medical review and signal detection/analysis activities as necessary. - Building and enhancing client relationships whenever possible. - Establishing and upholding a culture of high customer service. - Participating in process improvement activities across the company. Qualifications required for this position include: - Bachelor's degree in medical science or MD or DO or equivalent degree. - Relevant and equivalent experience may be considered in lieu of educational requirements. - Language Skills: English speaking at ILR level 3+ or higher, Writing/Reading: English at ILR level 4+ or higher. Experience required: - Working knowledge of medical sciences, diagnosis, and therapeutics, including drug treatments and procedures. - Knowledge of regulatory requirements for Clinical Research. - Understanding of ICH-GCP guidelines. Preferred qualifications: - Good understanding of regulatory requirements related to Pharmacovigilance. - Up to 1 year of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or 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. This position does not mention any additional details about the company. As a Medical Safety Expert, your role will involve providing medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. Your responsibilities will include: - Undertaking primary medical review of cases, including assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. - Updating and documenting daily case data and feedback in appropriate trackers/tools to ensure efficient tracking and workflow management. - Taking complete responsibility for assigned deliverables while maintaining expected quality, compliance, and productivity SLAs and KPIs. - Providing training and guidance to the case processing team on medical aspects of case processing after a tenure of 1 year. - Performing secondary medical review (QC role) and retrospective review of cases (QA role) to measure quality, identify error trends, training needs, and areas of improvement after a tenure of more than 1 year. - Conducting aggregate medical review and signal detection/analysis activities as necessary. - Building and enhancing client relationships whenever possible. - Establishing and upholding a culture of high customer service. - Participating in process improvement activities across the company. Qualifications required for this position include: - Bachelor's degree in medical science or MD or DO or equivalent degree. - Relevant and equivalent experience may be considered in lieu of educational requirements. - Language Skills: English speaking at ILR level 3+ or higher, Writing/Reading: English at ILR level 4+ or higher. Experience required: - Working knowledge of medical sciences, diagnosis, and therapeutics, including drug treatments and procedures. - Knowledge of regulatory requirements for Clinical Research. - Understanding of ICH-GCP guidelines. Preferred qualifications: - Good understanding of regulatory requirements related to Pharmacovigilance. - Up to 1 year of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or 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. This position does not mention any additional details about the company.
