Nikhil Sindhwani

Regulatory Specialist at Syneos Health Company

Role
Senior Regulatory Specialist at Freyr Solutions
Location
Gurugram, IN
LinkedIn followers
500 followers
Information TechnologyView LinkedIn profile

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

  1. Senior Regulatory Specialist

    Freyr Solutions

    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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Nikhil Sindhwani — Senior Regulatory Specialist at Freyr Solutions in Gurugram, IN | Unifers