Vaishnavi Barapatre

Drug Safety Associate (Quality Reviewer)

Pune,MH

Summary

Dedicated and results-oriented professional with 4 + years of experience in the Pharmacovigilance professional specialising in Individual Case Safety Reports processing and submission. Adept at utilising industry standard safety databases such as Arisg, Sapphire and LSMV. Seeking opportunities to contribute my expertise and drive operational excellence in the world of Pharmacovigilance.

Overview

years of professional experience

Work History

Drug Safety Associate

Indegene

11.2025 - Current

erformed quality review of ICSRs for accuracy, completeness, and regulatory compliance.
Verified case validity, seriousness, expectedness, causality, and medical coding (MedDRA/WHO-DD).
Ensured adherence to global SOPs, client conventions, and regulatory reporting timelines.
Reviewed narrative quality, medical assessments, and data consistency across safety databases.
Identified trends and recurring errors; provided feedback to case processors.
Supported CAPA activities and contributed to quality metrics and compliance monitoring.
Assisted in audit readiness and addressed audit/inspection findings.
Conducted case-based coaching and knowledge-sharing sessions to improve team performance.

Senior Process Associate

Tata Consultancy Services

04.2021 - 11.2025

Managed ICSR intake via data exchange systems and processed valid cases in LSMV/ARIS.
Ensured timely acknowledgment of ICSRs as per SOP and regulatory timelines.
Handled diverse case types: spontaneous, NIP/MAP, NIS, special situations, pregnancy, and product complaints.
Performed clinical assessments including case validity, seriousness, labeling, and company causality.
Generated follow-up queries and clarification requests; supported submission activities.
Reviewed invalid AR line listings from Business Partners.
Contributed to compliance monitoring, CAPA activities, and QC metrics.
Mentored new joiners through case-based training alongside Trainers and QRs.
Developed internal quizzes and engaged with clients to enhance training effectiveness.
Subject Matter Specialist for Special Situations, focusing on Medication Errors and Product Quality Issues.
Prepared safety presentations for teams and leadership forums.

Education

M. Pharma. - Pharmacology And Toxicology

Smt. Kishoritai Bhoyar College Of Pharmacy

Nagpur

04.2001 -

Skills

ADR, Serious Adverse Reaction, SUSAR, SAE, MedDRA

ICSR, SAE Reporting, Case processing, MedDRA Coding & Narrative Writing

Safety Database Systems & Knowledge of Medical Terminologies

Timeline