Summary
Overview
Work History
Education
Skills
Languages
Certification
Timeline
Generic

Jay Sangewar

Toronto,Canada

Summary

Detail-oriented Drug Safety Coordinator with 2+ years of pharmacovigilance experience including full-cycle ICSR processing, MedDRA coding, narrative writing, and regulatory submissions (ICH, FDA, EMA). Skilled in Argus, ArisG, and Sapphire safety databases. Demonstrated success in literature screening, aggregate report support (PBRERs, PSURs), case quality review, and training. Currently enhancing regulatory expertise through a PG Diploma in Regulatory Affairs & Quality Operations in Canada. Adept at collaborating with cross-functional teams and ensuring compliance with global PV standards.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Pharmacy Assistant Volunteer

Ultra Bloor Pharmacy
05.2024 - 04.2025
  • Supported prescription processing, data entry, and compliance packaging using Kroll PMS and PharmaClik
  • Assisted in final prescription checks, ensuring accuracy and adherence to OCP standards
  • Delivered professional, confidential customer service in both community and long-term care settings

Drug Safety Associate

Tata Consultancy Services
11.2020 - 03.2023
  • Processed ICSRs from clinical trials, spontaneous sources, literature, and post-marketing surveillance in compliance with ICH, FDA, and EMA guidelines.
  • Assessed seriousness, causality, expectedness, and case validity.
  • Performed MedDRA coding, narrative writing, and regulatory submission in Argus and ArisG databases.
  • Coordinated with local safety officers (LSOs) and global teams for data reconciliation and follow-ups.
  • Managed complex case types: spontaneous, literature, MLM, and solicited reports.
  • Participated in literature screening for case identification and aggregate report contributions.
  • Mentored junior associates and reviewed their cases for accuracy and compliance.
  • Supported audit readiness and internal QA initiatives; acted as backup team lead.
  • Drove process improvement and compliance by addressing root causes of late submissions and organizing refresher training sessions.

Education

Post Graduate Diploma - Regulatory Affairs and Quality Operations

Fanshawe College
04.2025

Bachelor of Pharmacy - undefined

Sant Gadge Baba Amravati University
12.2020

Skills

  • ICSR Processing (intake, triage, data entry, medical coding, narrative writing)
  • Safety Databases: Argus, ArisG, Sapphire
  • MedDRA Coding Causality Assessment Case Validity Review
  • Compliance: ICH E2B(R3), FDA, EMA, Health Canada
  • Aggregate Report Support: PBRER, PSUR, DSUR
  • Literature Screening Signal Management Basics
  • Cross-Functional Collaboration Training and Mentorship
  • Audit Support Process Improvement

Languages

English
Full Professional
Hindi
Native or Bilingual

Certification

  • Pharmacovigilance Practical ICSR – Udemy
  • Pharmacovigilance Aggregate Reporting – Udemy

Timeline

Pharmacy Assistant Volunteer

Ultra Bloor Pharmacy
05.2024 - 04.2025

Drug Safety Associate

Tata Consultancy Services
11.2020 - 03.2023

Bachelor of Pharmacy - undefined

Sant Gadge Baba Amravati University

Post Graduate Diploma - Regulatory Affairs and Quality Operations

Fanshawe College

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Jay Sangewar