SHILPA GUPTA
Thane
Summary
Pharmacovigilance professional with 2.5 years of experience in case processing, medical review, safety database management, and regulatory compliance. Adept at ensuring data accuracy, conducting root cause analyses, and driving continuous quality improvement. Skilled in Argus Safety, MedDRA coding, and pharmacovigilance quality review. Recognized for delivering error-free safety data, leading training sessions, and optimizing processes to meet global compliance standards.
Overview
12
12
years of professional experience
Work History
Quality Reviewer
Tata Consultancy Services
11.2024 - 08.2025
- Served as SME and client-facing reviewer for pharmacovigilance case processing and quality assurance.
- Ensured compliance with regulatory requirements by reviewing narratives, MedDRA coding, drug-event relationships, and case assessments in Argus Safety.
- Conducted literature screening, mailbox reconciliation, and SDEA management.
- Led CAPA initiatives, addressing errors with effective corrective and preventive measures.
- Trained and mentored team members on PV protocols and regulatory compliance.
- Performed pharmacovigilance tasks such as case nullification and deletion, ensuring data accuracy.
- Conducted reviews of case data captured by processors, identified discrepancies, and implemented corrective measures.
Senior Process Associate
Tata Consultancy Services
03.2023 - 08.2025
- Processed and validated ICSRs in Argus Safety, ensuring adherence to SOPs and global regulations.
- Conducted duplicate checks, assessed case seriousness, and ensured timely follow-ups.
- Created and reviewed medical case narratives and coded AEs using MedDRA terminology.
- Ensured global listedness assessments and compliance with submission timelines.
Pharmacovigilance Associate
IPC Ghaziabad
09.2013 - 04.2014
- Processed ICSRs using Vigiflow and coded events with MedDRA.
- Monitored safety data in line with ICH & GCP guidelines.
Education
M. Pharmacy - Pharmacy Practice
Punjabi University
Patiala10.2012
B. Pharmacy -
Rajasthan University of Health Sciences
Jaipur08.2009
Skills
- Databases: Argus Safety, Vigiflow
- Coding/Review: MedDRA, Medical Narratives
- Analytical Thinking
- Critical Problem-Solving
- Team Collaboration
- Planning & Organization
Core Competencies – Quality Reviewer (Pharmacovigilance)
- Quality Review & Case Assessment
- Regulatory Compliance (ICH, GCP, Global PV Guidelines)
- MedDRA Coding & Medical Narrative Review
- Safety Database Management (Argus, Vigiflow)
- CAPA Implementation & Root Cause Analysis
- Training & Mentoring of Teams
- Literature Screening & Safety Agreement Management (SDEA)
- Process Optimization & Stakeholder Communication
Timeline
Quality Reviewer
Tata Consultancy Services
11.2024 - 08.2025
Senior Process Associate
Tata Consultancy Services
03.2023 - 08.2025
Pharmacovigilance Associate
IPC Ghaziabad
09.2013 - 04.2014
M. Pharmacy - Pharmacy Practice
Punjabi University
B. Pharmacy -
Rajasthan University of Health Sciences