Yogesh Jadhav
- Role
- Safety and Pharmacovigilance Specialist Ii at Technical Resources International, Inc.
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Yogesh Jadhav
A dedicated professional with a passion for ensuring the safety of patients within the…
Experience
Safety and Pharmacovigilance Specialist Ii
Technical Resources International, Inc.
Jul 2021 — Present
Assisted the task manager in the preparation and modification of project work instructions (PWI) and client notification templates as required • Reviewed incoming SAE data for completeness and accuracy and acknowledged research sites • Performed data entry in Argus safety database including MedDRA and WHO-DD coding of adverse reactions and drugs, medical information of the study subject, and causality assessment of SUSAR, non-SUSAR, and fatal/life-threatening SAEs • Ensured accurate finding of expectedness using investigator brochure and/or package insert with written case summary • Contributed to the generation and tracking of IND safety reports (MedWatch) for submission to regulatory authorities and CIOMS I reports for distribution to pharmaceutical collaborators • Prepared site queries as well as responded to queries from pharmaceutical collaborators on case-specific deficiencies • Participated in the reconciliation activities including Medirave and argus safety database review, query drafting, and site follow-up every month with minimal supervision • Contributed to the preparation of internal SOPs and QC checklists considering applicable FDA and ICH regulations • Mentored associates on various aspects including triage QC, case processing, pharmaceutical and site queries, and reconciliation process • Collaborated with safety physicians, distribution team, and triage teams to identify and resolve case-related discrepancies
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