Medical Reviewer

Medical Reviewer

Golden Opportunities Private Limited
Mumbai Pune
1 - 10 Years
Not Specified

Job Description

Medical Reviewer


Job Location: Mumbai & Pune

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.
  • Performed review of eCRF for cancer/neoplasm events for assessment of protocol defined criteria and report it in timelines
  • Excellent communication is required.

Golden Opportunities Pvt. Ltd

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