This advanced program provides comprehensive training in pharmacovigilance principles and global drug safety practices. The syllabus covers adverse drug reaction (ADR) identification, collection, assessment, and reporting, with hands-on understanding of Individual Case Safety Reports (ICSRs) and case processing workflows.
Students are trained in signal detection and risk management, including qualitative and quantitative methods, benefit–risk assessment, and interpretation of safety data. The course includes global regulatory guidelines such as ICH, WHO, US FDA, EMA, and CDSCO requirements, ensuring alignment with international standards.
The program also covers pharmacovigilance databases and safety systems, including MedDRA coding, WHO-UMC causality assessment, periodic safety update reports (PSURs), periodic benefit–risk evaluation reports (PBRERs), and risk management plans (RMPs).
Additional modules include clinical trial safety monitoring, post-marketing surveillance, pharmacovigilance audits, quality management systems (QMS), and compliance documentation. Practical exposure is provided through case studies, real-world scenarios, assignments, and final evaluation, preparing students for roles in drug safety, regulatory compliance, and clinical research.
Eligibility: Pharmacy and life science students.
Outcome: Job-oriented skill development with industry-relevant certification by BioResire.
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