Pharmacovigilance & Drug Safety Learning Path

The Pharmacovigilance & Drug Safety Learning Path is designed to provide comprehensive training on the core processes, regulatory expectations, and operational activities involved in modern pharmacovigilance and drug safety management. Covering essential topics such as adverse event reporting, case handling, signal detection and risk assessment, PSUR and PBRER management, literature monitoring, and AI applications in pharmacovigilance, this programme equips professionals with the practical knowledge required to support global drug safety activities throughout the product lifecycle.

Participants will develop an understanding of pharmacovigilance systems, safety data evaluation, benefit-risk assessment, regulatory reporting requirements, and medical writing processes aligned with international standards and industry best practices. The programme also explores emerging technologies and AI-driven approaches transforming pharmacovigilance operations and safety surveillance.

How this differs from the PV Learning Path

The Pharmacovigilance & Drug Safety Learning Path is more operational and process-focused, with strong emphasis on case handling, safety reporting, literature screening, PSUR/PBRER management, and AI applications in pharmacovigilance. It is designed for professionals involved in day-to-day pharmacovigilance activities and drug safety operations.

In comparison, the broader PV Learning Path focuses more on strategic and regulatory pharmacovigilance topics such as global PV regulations, medical device vigilance, signalling and risk management, audit readiness, and overall pharmacovigilance compliance frameworks. It is more suitable for professionals seeking wider regulatory and oversight knowledge across global pharmacovigilance systems.

• Pharmacovigilance and drug safety professionals involved in case processing and safety evaluation.
• PV case processing associates, safety specialists, and clinical safety team members.
• Medical writers, regulatory affairs professionals, and pharmaceutical/CRO professionals handling safety reporting.
• Medical writers, regulatory affairs professionals, and pharmaceutical/CRO professionals handling safety reporting.
• Healthcare professionals transitioning into pharmacovigilance, life sciences graduates, and individuals interested in AI-driven drug safety careers.