Job title: Medical Reviewer
Company: Tata Group
Job description: 1.Accountablefor the medical review of relevant clinical and spontaneous cases (includingliterature articles), medical assessment (including listedness and causality)and overall cohesiveness of individual case safety reports for a particularproduct o
1. Accountablefor the medical review of relevant clinical and spontaneous cases (includingliterature articles), medical assessment (including listedness and causality)and overall cohesiveness of individual case safety reports for a particularproduct or group of products on a national, regional, or global basis in linewith regulatory and SOP requirements. 2. Accountablefor the final medical review of ICSRs including decisions on potential SUSARsin a timely fashion and ensuring that all necessary queries have beenaddressed. 3. Perform tasks such as writing Analysis ofSimilar Events, safety letters, communication with theappropriate Safety Science Leader and where appropriate with the ClinicalScience Group 4. Responsiblefor generating, sending and tracking data queries, together with other PDSOstaff, to Affiliates, SAE responsible and regional centers. 5. Developingand maintaining knowledge of the appropriate disease biology areas for marketeddrugs and drugs in development for which the Safety Operations Physician isresponsible. 6. Working in collaboration withRoche as needed to ensure a timely response to relevant safety queries fromRegional Centers, SAE responsible and corresponding affiliates, in particularthose associated with SUSARS and SARs. 7. &nbs p Responsible for developing close linksand communication with relevant Safety Operations Medical Lead, relevantSafety Operations Physicians groups maintaining awareness of critical AEs/andother issues for assigned product(s). 8. Conducting/ supporting individualcase safety data entry assessment and medical review according to Roche SOPsand guidelines. 9. Supporting the Drug Safety teamswith medical concepts and awareness of product related topics to ensure qualityof adverse event data processing. 10.
Expected salary:
Location: Mumbai, Maharashtra
Job date: Wed, 06 Jul 2022 22:26:23 GMT
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