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Nandini Singh

Nandini Singh

Pharmacovigilance Quality Specialist | Oracle Argus SME

nandini-singh-7435
Pune/Pimpri-Chinchwad Area
Joined July 2026
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Summary

Experienced pharmacovigilance quality specialist focused on regulatory-compliant drug safety systems.
Hands-on Oracle Argus Safety SME with expertise in E2B(R3) reporting and global regulatory requirements (FDA, EMA, ICH).
Quality management and process-improvement practitioner experienced in CAPA management, audit readiness, SOP development, and KPI/KQI monitoring to ensure inspection-ready PV processes.
Technically skilled analyst with certifications in Oracle Argus Safety, SQL, Tableau, Power BI, and Generative AI for Pharmacovigilance, combining data tools with PV expertise.
Committed professional credentials and knowledge-sharing: holds a PGDM in Project Management, is PMP certified, and has authored pharmacovigilance guidance on ICSR submission timelines. scribd

Work

Education

Writing

ICSR Submission Timelines in Pharmacovigilance

A short PDF outlining the importance of Individual Case Safety Reports (ICSRs) and detailing submission timelines for serious and non-serious adverse events, including regional variations across the US, EU, UK, India, and Japan.

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