A Textbook On Pharmacovigilance

About Author

Dr. Neetu Chopra is a dynamic professional with 13 years of diverse experience, including 5 years in Pharmacovigilance (PV), and 09 years’ experience in Research and Academic. She is working as Associate professor in Chandigarh College of Pharmacy Landran, Mohali, India. She has 22 publications in national and international Journal. She has published 4 books in national and international Publisher. She possesses expertise in MedDRA coding, Oracle Argus drug safety database, literature review and have a thorough understanding of safety documentation, including Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR). Her proven ability to contribute to drug safety and regulatory compliance is complemented by her proficiency in adhering to guidelines set by global health authorities, including the FDA and EMA, ensuring the highest standards of safety in drug development and post-marketing surveillance. She is skilled in Wet Lab Synthesis, Computational Studies, Anticancer evaluation and conducting thorough safety data analyses, preparing comprehensive safety documents and utilizing electronic reporting systems such as ARISg and Oracle Argus. As a collaborative team player, she is excelling in communicating effectively across cross-functional teams and have facilitated training sessions and presentations on safety protocols. Her commitment to continuous improvement and upholding quality assurance practices within pharmacovigilance operations and continuous innovation in Pharmaceutical Sciences drives her dedication to maintaining excellence in all aspects of her work. Dr. Rahil Manchanda is a dynamic professional with 11 years of diverse experience, including 10 years in Pharmacovigilance (PV), and 01 years’ Clinical experience. He is working as Manager, Tata Consultancy Services, Mumbai. He has expertise in CCC writing, medical review, MedDRA coding, Multiple databases (Argus, ArisG, Sapphire, Sceptre,etc), literature review, signal assessment and aggregate report writing. He has worked across various multi-national organisations gathering multitude of experience in this field. His expertise in working with industry-standard drug safety databases and his ability to mentor and train professionals in the field reflect his commitment to advancing healthcare standards.