Smita Kadam
Pharmaceutical Professional | Topical & Cosmetic Formulation Consultant | Speaker & Workshop Trainer | Quality & Technology Transfer Expert | Entrepreneur | Freelancer | Open for Collaborations & Industry Projects
- Role
- Drug Safety Specialist at Tata Consultancy Services
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Smita Kadam
I am a dedicated pharmaceutical professional with over a decade of versatile experience…
Experience
Drug Safety Specialist
Oct 2022 — Present
1.Recieves and processes indivisual case safety reports (ICSR e.g. Serious adverse events, adverse events of special interest and suspected ADRs)from clinical trial, spontaneous (Post Marketing Surveillance) and frompublished reports (e.g. literature, received from Regulatory Authorities)2.Tracking of received ICSR.3.Case data entry and case processing of Serious, Non-Serious, Lack OfEfficacy, Non-Intervention Study, Invalid, Death/Life-threatening Cases.4.Review of cases.5.Coding terms as appropriate.6.Sending the pending query reports to sites.7.Narrative writing.8.Working knowledge of ICH/GCP guidelines and MedDRA and WHO DRUGdictionaries.9.Updating narratives when updated information is received, asappropriate listing with customer/marketing authorization holders,executing case closure, reconciliation and preparation of events forarchiving.10.Monitoring on the new collegues on case processing and QualityReview.*Contributing to online/offline Quality Review of entered data.
Education
Rajiv Gandhi University of Health Sciences
Master's degree, Master in Pharmacy (Pharmaceutics)
2011 — 2013
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