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Introduction to Pharmacovigilance (Theory)

By Prof. Kashmira Kailas Malusare, Prof. Nagargoje Sangram Gangadhar & Praveen Rao

Pharmacovigilance is the science that keeps the promise a medicine makes. When a drug is approved, its benefits have been shown and its common harms are known, but its rarest and most delayed harms are not, because the trials that precede approval are too small and too short to find them. Pharmacovigilance is the organised watch that continues for the whole life of a medicine, detecting the harms that only wide use reveals, assessing whether the medicine is to blame, and acting to protect the patients who take it next. This book teaches that watch as a single working system rather than a set of separate topics.
Category
Pharmacovigilance
Target Audience
B.Pharm Students & Drug Safety Professionals
Course
B.Pharm Semester VII - BP705T
Edition
1st Edition
ISBN
978-81-689048-7-3
Syllabus
New PCI 2026 (NEP 2020)

About This Book

This book teaches pharmacovigilance as a single working system rather than a set of separate topics. Every chapter is reached through one practical question: how would a safety professional actually act here? The safety cycle of detection, assessment, decision and communication runs through the whole book, from the first suspected reaction reported by a clinician to the global signal detected across millions of records.

The same method is shown to serve not only medicines but vaccines, blood, devices, cosmetics, herbal products and even the environment. The Indian frame is kept central throughout, with the Pharmacovigilance Programme of India, the Indian Pharmacopoeia Commission, and the Central Drugs Standard Control Organisation treated as the working environment an Indian graduate will operate within.

Keywords

Pharmacovigilance Drug Safety Adverse Drug Reactions Signal Detection Risk Assessment PvPI CDSCO Vaccine Safety Medical Devices BP705T B.Pharm PCI Syllabus 2026

How to Cite

Malusare, K. K., Nagargoje, S. G., & Rao, P. (2026). Introduction to Pharmacovigilance (Theory) (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-689048-7-3

DOI: 10.66079/wiseleaf.intro-pharmacovigilance-bp705t.2026

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