Keerti Chaudhari-Kolhe
Periodic Report Submission @Tata Consultancy Services
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WORK HISTORY
Periodic Report Submission @Tata Consultancy Services
Mumbai, IN
Schedule the upcoming periodic reports submission. Prepare the submission package and proceed with the timely submission.
EDUCATION
Ramnarain Ruia College - Mumbai
Postgraduate Diploma in Clinico-Regulatory, Clinical Research and Regulatory Compliance
Shreemati Nathibai Damodar Thackersey (SNDT) Women's University, Mumbai
Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration
Cliniminds
Postgraduate Certificate Programme in Drug Safety Management, Pharmacovigilance
ABOUT KEERTI CHAUDHARI-KOLHE
With over a decade of experience in pharmacovigilance and clinical research, I currently contribute to Tata Consultancy Services as an nRSI Coordinator. My expertise spans the preparation and maintenance of Reference Safety Information (RSI) documents for non-company products in clinical trials, ensuring strict compliance with EMA, MHRA, US FDA, and other regulatory bodies. Passionate about facilitating safe and effective clinical trial outcomes, I am motivated to align my efforts with TCS\'s commitment to regulatory excellence and innovation. At TCS, I support safety surveillance by leveraging both internal and external databases such as FAERs, VigiBase, and Eudravigilance to identify and prioritize safety signals. I also contribute to safety monitoring for targeted and designated medical events, preparing critical safety reports, and mentoring team members. This role highlights my ability to drive safety compliance and collaborative growth, ensuring high-quality outcomes in clinical development.
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