Pharmacovigilance for Biologics Explained: Ultimate Guide to Post-Marketing Safety and Compliance Mastering Pharmacovigilance for Biologics: Compliance-Ready Guide for Regulatory Affairs Professionals Introduction to Pharmacovigilance for Biologics and Its Importance Pharmacovigilance (PV) for biologics refers to the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems associated with biological products, including monoclonal antibodies, vaccines, biosimilars, and advanced therapies. Given their structural complexity and potential for immunogenicity, biologics present unique safety monitoring challenges compared to small-molecule drugs. Regulatory agencies such as the FDA, EMA, and CDSCO have mandated stringent pharmacovigilance frameworks for biologics. By 2025,…