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Pharmacovigilance > Intermediate
Pharmacovigilance Aggregate Reporting: PBRER, DSUR, PADER & Signals
A comprehensive course on pharmacovigilance aggregate reporting - PSUR/PBRER, DSUR, and PADER under ICH E2C(R2) and ICH E2F, signal detection and evaluation, benefit-risk writing, and report finalization. Includes a full set of hands-on workshops covering planning, drafting, QC, AI-assisted summarization, and interview preparation, finishing with a capstone walkthrough and 30-day practice plan.
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What you'll learn
- Differentiate PSUR/PBRER, DSUR, and PADER and explain when each is required
- Apply ICH E2C(R2) and ICH E2F frameworks to structure aggregate safety reports
- Detect, evaluate, and document safety signals and emerging safety issues
- Write clear benefit-risk evaluations and safety summaries
- Use AI responsibly for literature review, summarization, and report QC while maintaining traceability
Course content
Welcome to the Course
What Aggregate Reporting Is and Why It Matters
How This Course Is Structured
Single Cases vs Aggregate Safety Data
The Purpose of Periodic Safety Reports
How Aggregate Reporting Fits into the PV System
Key Stakeholders PV Medical Regulatory Quality and Affiliates
Requirements
- Basic understanding of pharmacovigilance concepts (adverse events, case processing) recommended
- No coding experience needed
Description
A comprehensive course on pharmacovigilance aggregate reporting - PSUR/PBRER, DSUR, and PADER under ICH E2C(R2) and ICH E2F, signal detection and evaluation, benefit-risk writing, and report finalization. Includes a full set of hands-on workshops covering planning, drafting, QC, AI-assisted summarization, and interview preparation, finishing with a capstone walkthrough and 30-day practice plan.
This course is designed for:
- Pharmacovigilance professionals moving into aggregate reporting roles
- Drug safety associates and signal management analysts
- Regulatory and medical writing professionals supporting periodic safety reports
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 62 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.