Pharmacovigilance System

Pharmacovigilance System introduces the core components needed to monitor the safety of medicinal products after authorization. This course explains how pharmacovigilance systems support regulatory compliance, case processing, safety monitoring, risk management, and collaboration across functions and external partners to help protect patients and maintain product safety.
You will gain a practical understanding of how safety information is identified, assessed, documented, and managed within a pharmacovigilance system. The course explores valid safety cases, safety databases, case processing steps, the role of the EU-QPPV, the purpose of the PSMF, core risk management concepts, and how supplier and alliance relationships support pharmacovigilance activities.
The course focuses on key aspects of pharmacovigilance systems in practice, including:
    • How pharmacovigilance systems support ongoing product safety monitoring
    • Valid case recognition, safety information sources, and case processing
    • Safety databases, signal detection, and risk management activities
    • Key documents, roles, supplier oversight, and pharmacovigilance agreements
Through structured explanations and practical examples, this course helps learners understand how pharmacovigilance systems operate and why they are critical for compliance and patient protection. It is best suited to professionals who are new to pharmacovigilance or who need a clearer understanding of how pharmacovigilance systems function in regulated environments.