Exciting Opportunity for the Role of Medical Reviewer in Mumbai Location with one of the Leading MNC servicing the Leading Communication Fortune 100 companies. CTC best in the industry.
Work Timings: Candidates should be flexible working in a 24*7 environment Job Description: Medical review of the ICSRs (clinical spontaneous Drug surveillance literature and spontaneous) adhering to SOP designed by client. Keeping track of updates of the drug and cascade to drug safety pharmacovigilance into clinical trials. Communication and discussion with the client to assure case coding with adherence to coding Guidelines. Retrospective review of the line listing ICSRs within time-lines.. Training DSAs on guidelines submission and labeling aspect of the case. Safety package drafting and mailing it to client within timelines to assure in time 7-15 day SUSAR Submissions. Solving of queries from DSAs regarding Med-Dra coding labeling and narrative of the ICSRs. Involved in review in eCRF for protocol defined criteria like event of special interest endpoints and Sentinel events etc.