This module provides an overview of pharmacovigilance principles and the critical role Medical Affairs professionals play in supporting patient safety throughout the product lifecycle. Learners will explore key pharmacovigilance concepts, safety reporting requirements under ICH E6(R3), and the responsibilities of Medical Affairs in recognizing, documenting, escalating, and communicating potential safety information. The course also examines post-marketing pharmacovigilance activities, safety data sources, global guidance documents and reporting systems, and best practices for maintaining data integrity, participant protection, and regulatory compliance. Through real-world scenarios and practical examples, learners will gain the knowledge needed to identify potential safety information and support effective safety reporting processes.

This module takes an average of 2 hours to complete.

This eLearning module can be purchased individually or as part of the Medical Affairs eLearning Program (11 modules).