Full course description
Pharmacovigilance is a shared responsibility across the organization. This course provides employees with practical guidance on recognizing and reporting safety information related to medicinal products.
Through short lessons, real-world examples, and interactive scenarios, participants learn what qualifies as safety information, how to report it correctly, and why timely reporting is critical for patient safety and regulatory compliance.
Course Content
-
Introduction to pharmacovigilance and patient safety
-
Regulatory expectations and employee responsibilities
-
Adverse events, adverse drug reactions, and serious events
-
Safety information from real-life situations and communication channels
-
The “Golden Rules” of reporting and the 24-hour requirement
-
How to report safety information internally
-
What happens after a report and why escalation matters
By the end of the course, participants will be able to recognize potential safety information and promptly report it according to company procedures.