ICSR, case processing, MedDRA, timelines, and interview prep
This course contains the use of artificial intelligence.
What you’ll learn
- Explain how pharmacovigilance case processing works from intake to reporting.
- Identify valid ICSRs using the four minimum criteria and Day 0 logic.
- Apply core PV concepts such as seriousness, expectedness, causality, and listedness.
- Use MedDRA basics, coding logic, and narrative-writing principles in practice.
- Understand common reporting timelines, follow-up strategy, and QC checkpoints.
- Speak more confidently about PV workflows in job interviews and entry-level roles.
Course Content
- Introduction & Course Navigation –> 2 lectures • 12min.
- Module 1 – The PV Career Map –> 4 lectures • 27min.
- Module 2 – PV Foundations Without the Fluff –> 4 lectures • 27min.
- Module 3 – Sources of Safety Cases –> 4 lectures • 29min.
- Module 4 – Valid ICSR Criteria and Triage –> 4 lectures • 28min.
- Module 5 – Case Processing Workflow End to End –> 4 lectures • 28min.
- Module 6 – MedDRA and Product Coding Basics –> 4 lectures • 28min.
- Module 7 – Seriousness, Expectedness, and Causality –> 4 lectures • 28min.
- Module 8 – Regulatory Timelines and Reporting –> 4 lectures • 28min.
- Module 9 – Aggregate Reporting and Signal Basics –> 4 lectures • 28min.
- Module 10 – PV Systems and Cross-Functional Work –> 4 lectures • 28min.
- Module 11 – Job Readiness and Interview Preparation –> 4 lectures • 28min.
- Module 12 – Capstone and Next Steps –> 4 lectures • 28min.
Requirements
This course contains the use of artificial intelligence.
Pharmacovigilance is one of the most practical and employable areas in the life-sciences industry, but many beginner courses stay too theoretical. This course is designed to help you build real job-ready pharmacovigilance knowledge with a strong focus on ICSR workflow, case processing, MedDRA basics, reporting timelines, and the language employers expect in entry-level PV roles.
In this course, you will learn how pharmacovigilance teams work across the safety lifecycle and how individual case safety reports move from intake to review, coding, follow-up, and reporting. You will understand the difference between key concepts such as adverse event, adverse drug reaction, seriousness, severity, expectedness, listedness, and causality. You will also learn how valid case criteria work, how Day 0 logic affects timelines, how duplicate detection and triage support quality, and how narrative writing and QC discipline improve the case record.
The course also introduces MedDRA structure, verbatim-to-term coding logic, product and indication context, expedited reporting logic, aggregate reporting basics, signal detection basics, and benefit-risk thinking for beginners. Beyond theory, the course is built to help you speak clearly and confidently about pharmacovigilance workflow in interviews and early-career settings.
This course is ideal for PV beginners, pharmacy and life-science students, healthcare professionals, and job seekers who want a structured and practical introduction to pharmacovigilance operations. By the end of the course, you will be able to understand how a safety case is handled, explain core PV concepts more confidently, and connect course knowledge to real-world drug safety work.