Nilam Sukre
Drug safety and PV Specialist
- Role
- Senior Drug Safety Specialist at Tata Consultancy Services
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Nilam Sukre
Experienced Senior Drug Safety Specialist with a proven track record in end-to-end case…
Experience
Senior Drug Safety Specialist
Jan 2024 — Present · Pune, IN
Handled end-to-end case processing and quality review for ICSRs, including spontaneous, literature, and solicited reports. •Reviewed device literature cases for validity, seriousness, causality, expectedness, and regulatory reportability. •Review ICSR details regarding patient, event and drug information, medical history, associated lab data and reporter information into safety database for all type of cases.•Maintained compliance with global pharmacovigilance regulations, device vigilance requirement and internal SOPs.Participated in periodic quality checks, deviation investigations to drive continuous improvement. Responsible for case allocation and MOM activity. •Responsible for quality review of spontaneous cases. •Insightful knowledge of WHO DD, MedDRA. •Insightful knowledge of Argus data base.
Education
Padmashri Dr. D.Y.Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune 411018
Bachelor of Pharmacy - BPharm
2015 — 2019
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