Sharad Shinde
Drug safety associate
- Role
- Senior Process Associate at Tata Consultancy Services
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Sharad Shinde
Having 4.5 years of experience in Pharmacovigilance. Currently working at TCS
Experience
Senior Process Associate
Oct 2023 — Present · Pune, IN
Managed ICSRs (Data entry) of all case types - spontaneous and health authority, Registry, Patient Support program, Clinical trial cases, Literature review.Data entry of individual case safety report (ICSR), Code adverse events, diseases, indications of medication and lab data using MedDRA and coding of drugs using WHODD and CPDReview and evaluate AE case information to determine validity of a case, seriousness and expectedness as per client and internal policies and procedures.Creating safety narrative using approximate safety template and in clinical manner considering chronology of the reported information.Review of data entered in safety database for completeness and accuracy.· Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Performed drug safely data management, corrections in the narrative, per review, case follow-up, adequate documentation of the defects and proper Duplicate search.Prioritization: Prioritization of cases as per regulatory days. Process current incoming cases in order to meet timelines. Review and evaluate AE case information to determine required action based and following internal policies and procedures.Meeting regulatory timelines as well as internal timelines.Participate in team discussion for both processing & product knowledge.
Education
Rasiklal M. Dhariwal Institute of Pharmaceutical Education and Research
Bachelor of Pharmacy - BPharm
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