Vishal Tekale
Pharmacovigilance scientist
- Role
- Operational Specialist-1 (Regulatory Reporting and Submission) at IQVIA
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Vishal Tekale
Experienced Processor with a demonstrated history of working in the information…
Experience
Operational Specialist-1 (Regulatory Reporting and Submission)
Jul 2021 — Present · Mumbai, IN
Active participation in process improvement plans.Prioritization of cases as per regulatory due dates and TAT.Conducting team connects.Reporting of SUSAR to RA\'s EC\'s, IRB\'s, post marketing in the USA and Europe in a timely manner by adhering to strict deadlines and protocols.Regulatory Submission of E2B, gateway reporting and transmission, Portal submissions, courier and Manual email submission of CIOMS, XML and MEDWATCH.Process improvement, CIOMS and E2B report submission, Client mailbox handling.worked As POC for Bulk mail submission to Macedonia and Kazakhstan in a timely manner by adhering to time strict deadlines and protocols.Reviewing the quality of the cases in terms of structured entry of serious and non-serious events.To check if the processor has extracted incremental information from initial and follow up reports and entered that information in to safety database.
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