Master PharmacoVigilance from A to Z .

What Will You Learn?

• By the end of this course, you will be able to:
• Understand and apply causality assessment methods to evaluate the relationship between a drug and reported adverse events
• Manage ICSR (Individual Case Safety Report) case processing from intake to submission, including triage, data entry, medical review, and reporting timelines
• Explain the role and responsibilities of the Marketing Authorization Holder (MAH) in pharmacovigilance, including case handling, submission, and regulatory compliance
• Perform signal management activities, including signal detection, validation, prioritization, assessment, and documentation
• Prepare for and successfully handle pharmacovigilance (PV) inspections, ensuring inspection readiness and compliance with regulatory expectations
• Develop and implement Risk Management Plans (RMPs) to identify, assess, and minimize risks associated with medicinal products
• Understand the design and purpose of Post-Authorization Safety Studies (PASS) and their role in ongoing drug safety evaluation
• Apply PV tracking and tracing systems to ensure accurate follow-up, documentation, and lifecycle management of safety data
• Ensure compliance with global pharmacovigilance regulations and guidelines (ICH, FDA, EMA)
• Maintain high standards of data integrity, quality, and consistency across all pharmacovigilance activities
• 🎯 Outcome
• Confidently handle end-to-end pharmacovigilance processes
• Support drug safety monitoring and regulatory submissions
• Be fully prepared for pharmacovigilance roles in the pharmaceutical industry.