Pharmacovigilance Professional Certificate

Learn to protect patients by detecting, assessing and reporting drug safety issues, from processing a single case report to managing signals and risk management plans.

Who it’s for

Life-science graduates, pharmacists, nurses and drug safety associates moving into pharmacovigilance, and professionals who need a structured grounding in EU and UK drug safety requirements.

What you’ll be able to do

• Explain the EU and UK pharmacovigilance framework, including GVP and the role of the QPPV
• Classify adverse events by seriousness, expectedness and causality
• Process an individual case safety report from intake to submission
• Code events with MedDRA and write clear case narratives
• Apply expedited reporting timelines for marketed products and clinical trials
• Describe signal detection and management
• Explain risk management plans, PSURs and DSURs

What’s included

• 8 in-depth modules, each with a structured lesson
• 8 module quizzes to check your understanding
• Worked examples and a practical exercise in every module
• About 45 hours of study, at your own pace
• Lifetime access, on any device
• Certificate of completion

How you study

Each module combines a structured lesson with a worked example, a practical exercise and key takeaways, followed by a short quiz. You need 70% to pass each quiz and can retake it as often as you like. Complete every module to finish the course.