Medical reviewer

Medical reviewer

Golden Opportunities Private Limited
Mumbai
0 - 4 Years
Not Specified

Job Description

Role:

  • Pharmacovigilance and option offering a good career as an alternate to clinical for Qualified Doctors. Pharmacovigilance is a process in clinical research for ascertaining the affects of drugs during clinical trials.
  • Job involves recording adverse events and creating drug safety reports which only a doctor qualifies to create. Freshers receive excellent training for end to end pharmacovigilance with steady growth prospects.

    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.
We are looking for MBBS or MD/MBBS Fresher’s & lateral candidates of any clinical / Non-Clinical experience.
MCI Registration is Mandatory

Golden Opportunities Pvt. Ltd

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