Headline

SPE - Pharmacovigilance Cognizant Technology Solutions Pune, Maharashtra

About

Pharmacovigilance professional at Cognizant Technology Solutions with strong expertise in ICSR case processing, case booking, and Quality Review (QC) of adverse event reports. Experienced in Argus Safety (Core & Affiliate), MedDRA coding, narrative writing, and medical/technical QC to ensure accuracy, completeness, and regulatory compliance with GVP and ICH-GCP standards. Skilled in handling spontaneous, clinical trial, and literature cases, performing MI reconciliation, supporting RCA and CAPA activities, and collaborating closely with safety physicians, QA, and global affiliate teams. Passionate about delivering high-quality, compliant safety data and continuously improving processes to support patient safety.

Location

Pune District

Work experience

SPE - Pharmacovigilance at Cognizant, Apr 2023 - Present · 3 yrs 2 mos, Pune District, Maharashtra, India, 1. Perform intake and booking of adverse event (AE) reports from various sources including spontaneous, clinical trial, literature, and post-marketing data 2. Enter case data accurately into safety database (Argus Affiliate / Argus Core) following client-specific SOPs and regulatory guidelines 3. Review source documents for completeness and validity before initiating processing workflows 4. Ensure proper MedDRA coding of reported terms and seriousness assessment as per regulatory definitions 5. Coordinate with case processors and safety physicians for medical assessment and follow-ups 6. Perform duplicate search and data reconciliation to ensure data quality and compliance 7. Adhere to global regulatory timelines (e.g., 15-day/7-day expedited reporting) 8. Ensure documentation is audit-ready and compliant with ICH-GCP, E2B, and company SOPs 9. Participate in internal audits and quality checks as required 10. Support team with training, mentoring, and knowledge sharing for case intake processes

Education

Master of Pharmacy, Pharmaceutical chemistry, Y.B. Chavan College of Pharmacy Aurrangabad.

Bachelor of Pharmacy, Yash Institute of Pharmacy Aurangabad