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Keywords / Skills : MBBS, MD, Pharmacology, Drug Safety

0 - 5 years
Posted: 2019-05-23

Industry
Pharmaceutical
Function
Pharmaceutical/Biotechnology
Role
Other Pharma - Medical Reviewer
Posted On
23rd May 2019
Job Ref code
GO/JC/11100/2019
Job Description
Medical reviewer

Experience: 0- 7 yrs 
Job Location: Mumbai & Pune

Job Description:
Job Responsibilities 
  • 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.
  • 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




About Company

Golden Opportunities Pvt. Ltd
About Recruiter
Divya Rani
Recruiter
Golden Opportunities Private Limited
...
Skills I hire for ITES, java, bpo, fresher
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