Archana Thakur
ICSR submissions specialist
- Role
- Icsr Submission Specialist at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Archana Thakur
Senior Drug safety associate, working in the Healthcare organisation. Skilled in Good…
Experience
Icsr Submission Specialist
Sep 2021 — Present · Bangalore Urban, IN
Performing ICSR submission activities to different geographies (EMA and UK) via electronic, semi-automatic and manual mode within timelines with adherence to regulatory guidelines and applicable standards and processes.Also, operating other functional activities associated with local case reporting E2B, CIOMS, Med-watch and fax email distribute and upload to document storage.Monitoring and escalating unresolved issues appropriately as per escalation process. Confirming the accuracy of scheduled reports against current reporting references and reporting matrix.Assessment and processing non- submission of reports as applicable.Perform reconciliation, documentation and tracking compliance related data. Reconciliation activities includes maintenance of records pertaining to number of cases for submission and submission status with date and time within specific intervals.Coordinate with different local affiliates to ensure timely submission to local regulatory authorities.Updating/Verifying late response for late reports in database.Providing training and mentorship to new joiners in team.Ensuring the reporting rules are configured and working as expected.
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