Fundamentals of Pharmacovigilance (PV)

The Pharmacovigilance (PV) course provides a comprehensive introduction to pharmacovigilance principles, processes, and regulatory requirements applicable across the pharmaceutical, biotechnology, healthcare, and life sciences industries. The course covers key concepts such as adverse drug reaction (ADR) identification and reporting, Individual Case Safety Reports (ICSRs), case processing, seriousness and severity assessment, causality assessment, signal detection, risk management, Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Good Pharmacovigilance Practices (GVP), and regulatory reporting requirements. Designed for students, freshers, and working professionals, this self-paced e-learning program helps learners develop a strong foundation in drug safety monitoring, patient safety, regulatory compliance, and pharmacovigilance operations. The course builds essential knowledge for identifying and evaluating safety concerns, maintaining accurate safety databases, supporting timely adverse event reporting, assessing benefit-risk profiles, and ensuring compliance with applicable pharmacovigilance regulations and industry best practices.