Golden Opportunities Pvt Ltd jobs - Medical Reviewer

Medical review of the ICSR's (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