Pharmacovigilance Case Handling

Once a drug or medical device reaches the market, the responsibility for monitoring its safety does not end. It evolves. Pharmacovigilance is the system that makes continued post-market safety surveillance possible, and the quality of case handling directly determines the reliability of that system.

This course walks learners through the end-to-end process of pharmacovigilance case handling, from data collection and report validation to triage, coding, quality management, and regulatory submission.

Developed by Regulatory Affairs experts with qualifications from Northeastern University, Boston, this course equips professionals with the knowledge to handle pharmacovigilance cases accurately and in line with regulatory expectations.

🚀 Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, recognized for audit and compliance purposes.
 
✅ Who Should Enroll?

• Pharmacovigilance and drug safety professionals
• Regulatory affairs specialists involved in safety reporting
• Clinical research and medical affairs personnel
• Quality assurance professionals supporting pharmacovigilance operations

 
🎯 What You’ll Learn?

• The scope and importance of pharmacovigilance in post-market safety surveillance
• How to receive, validate, and follow up on case reports
• Triage, duplicate search, data entry, and coding assessment procedures
• Quality management practices and common errors in case handling
• Regulatory submission requirements and timelines for safety reports

Curriculum

Introduction
 
Lesson 1: Pharmacovigilance and Pharmacovigilance Case Handling: Importance and Major Steps

• What is Pharmacovigilance?
• Why is Pharmacovigilance Necessary?
• Good Pharmacovigilance Practice

 
Lesson 2: Data Collection – Receipt and Validation of a Case Report

• Sources of Reports
• Receiving Data
• Validation of Reports

 
Lesson 3: Data Collection in Special Situations

• Pregnancy or Breastfeeding
• Pediatric Population
• Misuse, Abuse, or Overdose of Drug

 
Lesson 4: Triage, Data Entry, and Assessment

• Triage
• Duplicate Search
• Complete Data Entry

 
Lesson 5: Maintaining Quality and Avoiding Errors in Case Handling

• Quality Management
• Errors in Case Handling

 
Lesson 6: Transmission to Authorities and Further Action

• Submission of Safety Reports
• Submission Time Frames
• Market Withdrawal

 
Glossary

Conclusion

Quiz