Sachin Shisode
Drug Safety | Safety Submissions Specialist | ARGUS | MedDRA | Pharmacovigilance | WHODD |
- Role
- Safety Specialist at Tata Consultancy Services
- Location
- Parbhani, MH, IN
- LinkedIn followers
- 500 followers
About Sachin Shisode
Pharmacovigilance Specialist with 6+ years of progressive experience across global ICSR…
Experience
Safety Specialist
Jun 2022 — Present · Pune, IN
As a Submissions Specialist:• Identifying individual record submission/suppression to CRO, Distributor, Health Authority on basis ofcase report type, suspect drug, event, seriousness/causality and labelling of the event.• Sending ICSR to MAH (Market Authorization Holder) of non-company suspect drug.• Manually scheduling/Generate ICSR record to CRO, Health Authority, MAH, Ethics Committee,Investigator (Safety Letter) and Affiliate (e.g, CIOMS I, MedWatch 3500A, XML) as needed onRegulatory reports tab (ARGUS).• Working on ICSR record issues (negative ACK, failed to generate, pending ACK, failed nullificationACK and failed to transmit).• Working on missing informed dates (MIDs). Communicating with Third Parties/Distributor/CROs toknow authority submission dates as needed.• Uploading missing informed dates (MIDs) in ARGUS.• Working on monthly line listings (MLLs). Checking quality of sent MLL requests by Systems(automated) to Third Parties/Distributor/CROs.• Working as a Submissions Trainer.
Education
Maharashtra College of Pharmacy, Nilanga
Master's degree
2016 — 2018
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