UNIT 14: Pharmacovigilance Databases, E2B Reporting, and Automation
This unit explains how pharmacovigilance safety data are captured, stored, and transmitted using validated safety databases and standardized electronic reporting formats. It also introduces automation and emerging technologies used to improve efficiency, data quality, and regulatory compliance in modern PV operations.
Safety databases are specialized systems designed to collect, manage, analyze, and report pharmacovigilance data in a structured and compliant manner. These databases support the end-to-end ICSR lifecycle, enable regulatory reporting, and provide data for signal detection and safety analysis.
Key Points
Central repository for safety data.
Supports regulatory submissions.
Enables data analysis and trend monitoring.
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