About Book
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.
About Author
Authors Profiles
1. Mr. Abhay Joshi
Mr. Abhay Joshi is a researcher and Assistant Professor at Yash Institute of Pharmacy, Chhatrapati Sambhajinagar. With experience spanning academia and industrial research, his work focuses on molecular docking and the pharmacological evaluation of natural products on the cardiovascular system. He has authored multiple research articles, holds a German patent, and actively participates in faculty development initiatives, workshops, and institutional quality processes. He is currently pursuing his Ph.D. at Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar.
2. Dr. Vikas Rajurkar
Dr. Vikas Rajurkar is an accomplished academician and the Principal of Dr. Vedprakash Patil Pharmacy College, Chhatrapati Sambhajinagar. With strong expertise in pharmaceutical Chemistry and natural product research, he has contributed extensively through publications, academic leadership, and research mentorship. His dedication to advancing pharmacy education and fostering quality research has earned him recognition at both institutional and professional levels.
3. Ms. Manasi Mistry
Ms. Manasi Mistry is an Assistant Professor at Parul University with five years of experience in Pharmacy Practice. She specializes in clinical pharmacy, pharmacotherapeutics, research methodology, and medical writing. As Coordinator of the MDMC under the Materiovigilance Programme of India, she contributes to patient safety initiatives. She has guided multiple student research projects, published scholarly work, and earned awards for oral presentation, poster presentation, and blog writing, reflecting her commitment to academic excellence and healthcare advancement.
4. Mr. Sandesh Dahiwal
Mr. Sandesh Dahiwal is a researcher and Assistant Professor at OJAS college of Pharmacy, Jalna. With experience spanning academia and industrial research, his work focuses on Solubility enhancement of poorly water soluble drugs and the various. He has authored multiple research articles, holds a Indian patent, and actively participates in faculty development initiatives, workshops, and institutional quality processes. He is currently pursuing his Ph.D. at Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar.
5. Ms. Varsha Patwekar (Lad)
Ms. Varsha Patwekar (Lad) is an Assistant Professor at Dr. Vedprakash Patil Pharmacy College, Chhatrapati Sambhajinagar, and an accomplished writer known for producing scientifically accurate and clearly articulated content. With a strong understanding of industry standards and emerging trends, she effectively bridges complex scientific concepts with practical comprehension. Her work consistently reflects clarity, integrity, and educational value, contributing meaningfully to academic learning and professional development within the pharmaceutical domain.
