Shruti Wayal
Patient Safety Associate • M.Pharm • Indira college of pharmacy,Tathwade Pune.
- Role
- Safety Science Associate at Tata Consultancy Services
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Shruti Wayal
Triage and classify ICSRs for report type, seriousness, causality, labeling and reporting; prioritize ICSR according to regulatory requirements. •Confirm validity of case by identifying minimum criteria for case creation. •Perform duplicate search to create an initial case or a follow up case. •Attache the relevant source documents or any safety information/queries/following information that is relevant to cases. •Facilitite follow up based on queries from Data entry/QC/MR or based oninconsistent missing information in the source file. •Responsible For coding includes adverse event, medical, history,lab data, indications etc using standardized terminology form medical coding dictionary Such as MedDRA. •Code products Suspect/co- suspect, Concomitant as per regulatory requirement.•Completion of remaining case data entry, including narrative or auto- narrative •Prioritization of incoming cases for daily workflow management •Single case unblinding, Serious Adverse Event (SAE) reconciliation, deviation memo preparation, deletion/ requests as needed. •Perform Quality Review of ICSRs after the data entry
Experience
Safety Science Associate
Jul 2024 — Present
Education
Sppu
M.pharmacy
2021 — 2022
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