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Intermediate
8 weeks
720+ enrolled

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

8+ hours of on-demand video content
Adverse event reporting templates
Risk management plan examples
Certificate of completion
Lifetime access to course content
Access to course community forum

Course Format

Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.

Key Topics Covered

Pharmacovigilance principles and systems
Adverse event identification and reporting
Signal detection and analysis
Risk management plans
Global PV requirements
Post-marketing surveillance

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
$299
One-time payment
Enroll Now

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
Duration: 8 weeks
720+ students enrolled
Intermediate Level

This course is delivered through Thinkific. You'll receive access instructions after enrollment.