Pharmacovigilance & Drug Safety
About This Course
Protect patients and your company by mastering drug safety monitoring. This course teaches you how to build a pharmacovigilance system that catches safety issues early and keeps your products on the market. You'll learn how to collect, process, and report adverse events correctly, so you never miss critical safety signals or face regulatory penalties. We cover everything from setting up your PV system to detecting signals in large datasets and creating risk management plans that regulators accept. Whether you're handling your first safety case or managing a global PV program, this course gives you the skills to do it right. You'll understand how to prioritize safety data, communicate risks effectively, and maintain compliance across different regions. Most importantly, you'll learn how to balance patient safety with business needs, so you can make informed decisions that protect both.
What's Included
Course Format
Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.
Key Topics Covered
What You'll Learn
- Understand pharmacovigilance principles
- Process and report adverse events
- Develop risk management plans
- Conduct signal detection and analysis
- Comply with global PV requirements
Course Outcomes
By the end of this course, you will be able to:
- Process and report adverse events correctly
- Conduct signal detection and analysis
- Develop comprehensive risk management plans
- Comply with global PV requirements
- Manage post-marketing safety data
Who Should Take This Course
- Pharmacovigilance professionals
- Drug safety specialists
- Regulatory affairs professionals
- Medical affairs professionals
Course Content
Module 1: Pharmacovigilance Fundamentals
- PV principles and importance
- Regulatory framework
- PV systems and processes
Module 2: Adverse Event Reporting
- AE identification and collection
- Case processing and coding
- Expedited and periodic reporting
- ICSR requirements
Module 3: Signal Detection
- Signal detection methods
- Data mining techniques
- Signal evaluation
- Regulatory communication
Module 4: Risk Management
- Risk management plans
- Risk minimization measures
- Post-marketing studies
- PV inspections
This course is delivered through Thinkific. You'll receive access instructions after enrollment.