Nilesh Shinde

Experience

• 

  Cognizant

  Apr 2019 - Apr 2021

  Initial evaluation and case entry of all serious adverse event (SAEs), Non-serious and adverse events of special interest (AES's) in ArisG also case entry and coding of adverse events from clinical trials phase 1 to 4 based on initial adverse events report correspondence with medical advisors.Performed data verification between source data and ArisG database.Ensured accurate and consistent medical coding of all events entered in ArisG with the use of MedDRA (medical dictionary for regulatory activities).Evaluated event seriousness, causality and listedness.Narrative writing and ensured regulatory compliance by following internal reporting timeline.Utilized expertise in safety systems to investigate the status of reports and perform database queries for reconciliation purposes.Training and mentoring new employees on the process.Drug and device training.Responsible for case intake, duplicate checks and registration of cases in ArisG.Data entry of individual case safety reports into the safety database (ArisG).Review and evaluation of adverse events (AE) case information to determine relevant required action (Triage and Case seriousness).Maintaining internal timelines and external timelines for the case which goes for submission.Data entry, medical coding (using MedDRA) in correspondence with medical advisors and Narrative writing.Handling off-line cases (CCFs – Customer Complaint forms) Processing & archiving of cases.Handling and processing the E2B- Healthy authority, Business partner, cases. Show less

  • Junior Data Analyst

    Oct 2020 - Apr 2021

  • Trainee Junior Data Analyst

    Apr 2019 - Oct 2020
• 

  Qinecsa Solutions

  Apr 2021 - now

  Review data entered in safety database for completeness and accuracy.Provide quality feedback to team resources.Track and maintain quality metrics.Responsible for data entry of Individual case safety reports into the safety database.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process all incoming cases in order to meet timelines.Full data entry including medical coding and safety narrative.Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Responsible for Email intake, case intake, duplicate check, and registration of the case into the safety databaseMaintain log of source documents and other communicationsDetermine the validity of the case and complete the triage processResponsible for data entry of Individual case safety reports into the safety database.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process all incoming cases in order to meet timelines.Other responsibilities:• Follow up with sites regarding outstanding queries.• Follow up on reconciliation of discrepancies.• Follow departmental AE workflow procedures.• Closure and deletion of cases.• Mentor and guide the activities of the Drug Safety Associate.• High level of proficiency all workflow tasks.• Perform any other drug safety related activities as assigned. Show less

  • Senior Drug Safety Associate

    Jan 2023 - now

  • Drug Safety Associate II

    Apr 2021 - Jan 2023