WALKIN - Job Opportunity - Medical Reviewer ICSR /Aggregate Reporting- Mumbai

WALKIN - Job Opportunity - Medical Reviewer ICSR /Aggregate Reporting- Mumbai

Golden Opportunities Private Limited
Mumbai
1 - 6 Years
Not Specified

Job Description

Job description:

  • Performing the Case Analysis and Peer Review (Quality check)
  • Perform medical review (including verifying the coding & labeling reviewing narratives causality statement medical aspect of follow-up request)
  • validate follow-up request and perform medical assessment of the case for the Category I and II cases
  • Responsible for the timely reception of an individual case on a daily basis.
  • Aggregate (Medical Reviewer/Service Delivery Manager)
  • Draft and review of PBRERs with focus on medical aspects of the products and safety sections. Also collecting and analysing various safety trends for the product.
  • The preparation and medical review of SAR (signal assessment reports) reports Aggregate reports (PBRER/DSUR/ACO/AR/RMP/SER) and Medical and scientific Pharmacovigilance review of literature reports.
  • Draft and review of Risk Management Plans as per Regulatory requirement. Focus on the identification of risk and the categorization.
  • Assist in identification analysing and concluding safety data for any cumulative trends.

Golden Opportunities Pvt. Ltd

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