Tanvi Manchekar
Regulatory Document Publisher ( SPE-Reg Affairs Med Writing) at Cognizant Technology Solutions.
- Role
- Spe-reg Affairs-med Writing at Cognizant
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Tanvi Manchekar
A budding professional; currently working as a SPE-Reg Affairs Med Writing ( Regulatory document publishing Specialist) at Cognizant Technology Solutions, Navi Mumbai and worked as a Regulatory Document Specialist and Document Process Lead at Tata Consultancy Services, Thane. • Completed Post-Graduate diploma in Pharma Management from Garware Institute of Career Education and Development, Mumbai• Proficiency in grasping concepts such as Veeva Vault (RIM and Clinical), DocuBrigdge, BIRDS, ISI toolbox, Regulatory affairs (Document Publishing and Handling Mailbox).• Completed internship at Raptakos Brett & co. Ltd in the department of Regulatory affairs and Quality assurance in the year of 2019
Experience
Spe-reg Affairs-med Writing
Apr 2022 — Present · Mumbai, IN
Perform Pre-approval checks for clinical (CTP, CTR, BA, TSAP, NIS, Clinical summary, CEO, Extended synopsis) and safety report (RMP, PEBRER, DSUR, ASUR, ADDCO) to ensure quality for the report before sending to health authority for approval.• Redaction activity on CTP, TSAP, BDS, Safety, Summary document, Research proposal file which includes sensitive information of patients with 100% accuracy.• Report publishing, Work flow initiation, Re-publishing in first document (virtual Documents, importing/uploading, pre-approval checks).• Perform word as well as PDF formatting.• Perform Report level hyperlinking and Submission level hyperlinking in clinical and safety reports.• Publishing and editing tools used for regulatory e-submission i.e. Veeva Vault, Adobe acrobat professional, ISI toolbox, DocuBridge, BIRDS.
Education
Garware Institute of Career Education and Development
Diploma
2018 — 2019
Ramnarain Ruia College
BSc - Bachelor of Science
2017 — 2018
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