Nikhil Sindhwani
Regulatory Specialist at Syneos Health Company
- Role
- Senior Regulatory Specialist at Freyr Solutions
- Location
- Gurugram, IN
- LinkedIn followers
- 500 followers
About Nikhil Sindhwani
Regulatory Operations professional with 4 years of experience in CSC TRS Tracker for Regulatory Information Management (RIMS) for managing the Registration Tracking, Product Management (VEEVA Vault EV web tool, Athena tool, TRS Tracker Tool) Working on Athena tool to update SmPC and PIL documents Registration of new license updating via Ev web tool for xevmpd update Clinical Learning - Performing eTMF periodic review of documents for contents with reconciliation task such as missing document and duplicate checks Pharmacovigilance Learning - Complete understanding of ICSR case reporting on Argus tool Detection of meDRA Coding Expectedness/ Unexpectedness of ADR check via Veeva Vault document and Ability to deliver within established timelines
Experience
Senior Regulatory Specialist
Aug 2022 — Present · Hyderabad, IN
Education
Krupanidhi College Of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
2011 — 2015
JSS University (Jagadguru Sri Shivarathreeshwara University),Mysore
Doctor of Pharmacy - PharmD, Clinical, Hospital, and Managed Care Pharmacy
2015 — 2018
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