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Pharmacovigilance > Beginner
Pharmacovigilance Job Readiness Bootcamp ICSR & MedDRA
The complete practical bootcamp for breaking into pharmacovigilance. Covers ICSR case processing end-to-end, MedDRA coding, regulatory timelines, global safety databases, and signal detection fundamentals. Designed for life-science graduates, career-switchers, and PV professionals looking to strengthen their core drug safety skills.
Free preview lessons available — try before you buy
What you'll learn
- The complete practical bootcamp for breaking into pharmacovigilance
Course content
Welcome to the Course
How to Use This Course, Quizzes, and Assignments
What Pharmacovigilance Teams Actually Do
Common PV Roles and Career Entry Points
How Case Processing Fits into Drug Safety Operations
The End-to-End Workflow You Will Master in This Course
AE, ADR, SAE, and SUSAR Explained
Seriousness vs Severity vs Expectedness
Causality, Listedness, and Medically Important Events
Pre-Marketing vs Post-Marketing Safety
Spontaneous Reports and Contact Center Intake
Solicited Sources, Support Programs, and Market Research
Literature, Digital, and Partner Cases
Clinical Trial Cases vs Post-Marketing Cases
The Four Minimum Criteria for a Valid ICSR
Day 0, Follow-up, and Clock Start Logic
Duplicate Detection and Case Prioritization
Practical Walkthrough - Is This a Valid Case
Intake Triage and Intake Documentation
Building the Case Record Step by Step
Narrative Writing that Supports Medical Review
Quality Control Checkpoints and Common Errors
MedDRA Structure - Llt to Soc
From Verbatim to Preferred Term
Product Coding, Indication, and Concomitant Logic
Practical Coding Exercise - Choosing the Best Term
Assessing Seriousness with Real Examples
Expectedness and Listedness in Practice
Causality Concepts for PV Operations
Escalation Rules and When to Seek Medical Review
Expedited Reporting Timelines - What Must Move Fast
7-Day, 15-Day, and Other Common Reporting Rules
Follow-up Strategy and Submission Readiness
E2b, Case Submission Basics, and Audit Trail Thinking
Why Single Cases Are Not the Whole Story
PBRER, DSUR, and PADER for Beginners
Signal Detection Basics for Case Processing Professionals
Benefit-Risk Thinking for Beginners
How PV Systems Support Workflow
Safety Database Users, Fields, and Handoffs
Working with Medical Review, QC, Affiliates, and Vendors
Inspection Readiness and Documentation Discipline
Common Entry-Level PV Tasks Employers Expect
CV and Interview Language for PV Roles
Interview Questions on ICSR, MedDRA, and Timelines
Mock Case Exercise - Talk Through Your Decision
End-to-End Case Processing Simulation
Common Beginner Mistakes and How to Avoid Them
Build Your 30-Day PV Practice Plan
Final Wrap-up and Career Next Steps
Requirements
- No prior experience required unless stated in the lessons.
Description
The complete practical bootcamp for breaking into pharmacovigilance. Covers ICSR case processing end-to-end, MedDRA coding, regulatory timelines, global safety databases, and signal detection fundamentals. Designed for life-science graduates, career-switchers, and PV professionals looking to strengthen their core drug safety skills.
This course is designed for:
- SafeMeds Academy learners
- Life-science professionals building practical confidence
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 50 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.