The Certificate Course in Global Pharmacovigilance is a specialized professional training program designed to equip participants with both theoretical knowledge and practical skills in drug safety monitoring and risk management. It focuses on international standards and practices in pharmacovigilance, preparing learners to contribute effectively to patient safety, regulatory compliance, and global public health.
The course runs for a duration of three to six months, with flexible options that allow participants to study either part-time or full-time. Learning is delivered through a blended format, combining interactive online lectures, self-paced modules, and in-person or virtual workshops. This approach ensures that participants gain hands-on experience in adverse drug reaction (ADR) monitoring, case assessment, and safety reporting.
It is intended for healthcare professionals, including pharmacists, nurses, biomedical scientists, clinicians, public health experts, and regulatory officers who are seeking to strengthen their capacity in pharmacovigilance and drug safety systems.
This course provides comprehensive training in drug safety monitoring, adverse event reporting, risk management, signal detection, regulatory frameworks, and global pharmacovigilance systems. It equips learners with the skills needed to assess medication risks, ensure patient safety, and comply with international drug safety regulations throughout the product lifecycle.
The course is suitable for pharmacy graduates, medical practitioners, nurses, biomedical scientists, regulatory affairs professionals, clinical research staff, and anyone aspiring to work in drug safety. It is appropriate for both beginners and professionals seeking to build specialized competencies in pharmacovigilance.
Participants will learn how to collect, evaluate, and report adverse drug reactions, prepare Individual Case Safety Reports (ICSRs), analyze safety data, conduct signal detection activities, support risk management plans, understand regulatory workflows, and use global pharmacovigilance databases. The course emphasizes real-world practical skills required in pharmaceutical companies, CROs, and regulatory agencies.
The course covers ICH E2 guidelines, EU-GVP modules, FDA and EMA safety reporting requirements, WHO Uppsala Monitoring Centre systems, MedDRA coding principles, and Good Pharmacovigilance Practices. Learners also gain insight into post-marketing surveillance, clinical trial safety monitoring, and global harmonization efforts in drug safety.
Pharmacovigilance is a rapidly growing field with high demand for skilled professionals worldwide. Completing this certificate enhances employability in pharmaceutical companies, contract research organizations, health regulatory bodies, and global safety departments. It equips learners with job-ready competencies for entry-level to mid-level drug safety roles and strengthens their capacity to contribute to patient safety and regulatory compliance.
Associate Professor of English Language & Literature, Makawanpur Campus, Hetauda, Nepal (Affiliated to Tribhuvan University, Kathmandu, Nepal)
Copyright ©2025. Metascholar Institute. All Rights Reserved.
