UNIT 1: Introduction to Pharmacovigilance
This unit introduces Pharmacovigilance as a scientific and public-health–driven discipline focused on ensuring the safety of medicines throughout their lifecycle. It explains the core concept, WHO definition, objectives, historical evolution, and the origin of the term, forming the foundation for all advanced PV activities.
Definition
Pharmacovigilance is a medical and scientific profession which involved in patient and public safety in terms of medication use
Pharmacovigilance exists to ensure that medicines used in real-life clinical practice remain as safe as possible. Unlike clinical trials, which involve limited patient populations and controlled conditions, real-world use exposes medicines to diverse patients, long-term use, polypharmacy, and varying disease states. Pharmacovigilance continuously monitors medicines after administration to patients to identify previously unknown risks, changes in known risks, and patterns that may affect patient safety.
Key Points
Pharmacovigilance is focused on patient and public safety.
It applies throughout the entire lifecycle of a medicinal product.
It bridges clinical practice, regulatory science, and public health.
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