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The Pharmacovigilance Quality Management System

Review how to design, develop, and manage a quality system related to your pharmacovigilance system to achieve quality and regulatory compliance.


This eLearning course covers organizational structure, responsibilities, processes, and resources required for Pharmacovigilance Quality Management Systems (PV QMS). The module describes how elements of the PV QMS fit together to achieve quality and regulatory compliance.

Featured topics

    • Quality and the quality system
    • QMS regulatory framework
    • Applying QMS to pharmacovigilance
    • PV quality manual
    • Quality risk management
    • Quality documents
    • Compliance management and monitoring
    • Risk-Based and pharmacovigilance auditing
    • Record management and documentation of a QMS
    • Pharmacovigilance inspections and inspection readiness
    • Responding to inspection and audit findings
    • Corrective and Preventive Action (CAPA)

Who should attend?

  • The module is designed for professionals involved in quality assurance and PV compliance, PV audits, drug compliance, inspection support and/or pharmacovigilance quality documents. It is well suited for professionals involved in PV activities at a pharmaceutical company or external service provider. Personnel who are considering the PV QMS field as a future career path would also benefit from this module.

        Learning objectives

        • Upon completion of this course, learners should be able to:

          • Recognize the characteristics and benefits of a PV QMS
          • Differentiate between the elements of the regulatory framework that govern a PV QMS
          • Differentiate between the components of a complete PV Quality Manual
          • Select ways in which a PV QMS integrates into a PV system
          • Recognize characteristics of effective development, maintenance, and oversight of PV QMS documents
          • Identify factors for measuring and monitoring the effectiveness of a PV QMS
          • Select defining factors of successful risk-based audits of the PV QMS and define the audit universe
          • Sequence steps for effective preparation for audits and inspections
          • Classify PV audit or inspection observations and findings
          • Recognize elements of an effective Corrective and Preventive Action (CAPA) plan

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