Rupesh Mourya

About Rupesh Mourya

Handling E2B Group mail box. Handling of Import from EudraVigilance Handling of successful and unsuccessful Acknowledgements. Handling of R2 and R3 imports. Assigning cases of R2 and R3 cases within the team. Processing R2 and R3 cases. Taking hurdle on weekly basis for submission failure. Identifying and Handling of Parsing error. Handling E2B Reports. Monthly collating and maintaining the tracker for R2 cases and E2B Reports for billing. Handling and processing of R2 and R3 literature cases. Handling and processing of Translation for R2 and R3 cases. Giving consistently feedbacks to case processors and QR. Hands on experience of ARGUS 7.0 database Review and Triaging of cases based on validity, seriousness, timelines Data Entry of the adverse events report (AE) form from source documents Well acquainted with coding of adverse events, Medical History Drugs/Procedures, indication and laboratory tests according to the appropriate dictionary (For eg MedDRA, Company Product Dictionary, WHO-DD). Listedness assessment of adverse events (AE) using various labelling documents. Dealing with various big data medical records like discharge summary etc Delivering the ICSR on various case types including Spontaneous, NIP and PMS. Allocation of cases as per seriousness and regulatory timeline Narrative writing according to the regulatory standards for ICSRS, Clinical Data Cases, Post Marketing Surveillance reports with timely completion of the assigned data entry for expedited reporting Co-ordinate with Team Lead, Quality Reviewer, Medical Reviewer and Team Manager to ensure efficient case processing Back up team leader.

Experience

1. Operational Specialist 1

   IQVIA India

   Apr 2021 — Present · Thane, IN

Education

• University of Mumbai

  Master's degree

  2012 — 2015