Prachi Bodkhe

Experience

1. Drug Safety Associate

   Tata Consultancy Services

   Sep 2024 — Present · Thane, IN

   Acquainted with ARGUS database. • Performed end-to-end case processing of ICSRs (serious and non-serious) in Argus Safety database. • Handled NACK case management and correction. • Triage, assess, review and report the adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within the specified timelines by meeting the quality standards. • Well versed with of MedDRA and WHO-DD coding. • Triage and case processing of License partners cases (LP cases).E.g Daichi Sankyo, Amgen, etc and Regulatory authorities’ cases such as Health Canada, MHRA.• Review of adverse events for completeness, accuracy and appropriateness for expedited reporting, write patient narratives and code adverse events using MedDRA. • Coordinated with cross-functional teams and supported audits/inspections. Assessment of case reports for seriousness, case validation, causality, expectedness, and prioritizing the adverse event reports processing base on the ICH dates. • Coding of events, medical history, and laboratory test using MedDRA dictionaries.• Ensure accurate and timely submissions to global authorities (FDA, MHRA, EudraVigilance). • Quality review of individual Case Safety Reports (ICSR\'s).• Identify serious adverse events (SAEs) and special scenarios such as lack of efficacy, pregnancy cases, exposure cases, and product quality complaints. • Highlighting areas where improvement is required and ensuring corrective measures are taken. Validity assessment of case.

Education

• Bombay College of Pharmacy Kalina Santacruz (E) Mumbai - 400 098

  Bachelor of Pharmacy - BPharm

  2020 — 2024

• Seva Sadans R K Talreja College of Arts Science and Commerce Ulhasnagar Dist Thane 421 003

  Hsc

  2018 — 2020