Fundamentals of Pharmacovigilance

Fundamentals of Pharmacovigilance: Principles, Practice and Case Management is a comprehensive and practice-oriented guide designed for students, healthcare professionals, and beginners entering the field of drug safety. The book offers a clear and structured journey through the core concepts of pharmacovigilance, beginning with the foundational principles that define the science and its role in safeguarding public health. It then moves into the practical aspects of case processing and management, exploring event seriousness, causality assessment, labeling concepts, and the nuances of dechallenge–rechallenge. Readers are introduced to essential regulatory constructs such as Individual Case Safety Reports (ICSRs), SUSARs, and special-situation scenarios commonly encountered in industry practice. The book also explains global regulatory authorities, submission timelines, and the use of standardized medical terminologies, including MedDRA and WHO-Drug Dictionary, ensuring readers understand how consistent coding drives high-quality safety data. With its blend of theory, real-world relevance, and systematic chapter organization, this book serves as a valuable resource for learning, training, and applying pharmacovigilance principles in professional settings.