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AI in Pharmacovigilance: PBRER DSUR PADER Reporting
New
84 students
What you'll learn
- Understand PSUR, PBRER, DSUR, PADER, and how aggregate safety reports fit into pharmacovigilance.
- Identify key data sources used in aggregate reporting, including ICSRs, literature, exposure, and regulatory actions.
- Review safety data for signals, benefit-risk questions, important risks, and emerging safety issues.
- Build practical workflows for preparing, reviewing, and quality-checking aggregate safety reports.
- Use AI responsibly to support summaries, literature review, trend checks, and report drafting without losing traceability.
- Prepare for aggregate reporting roles, interviews, and real-world PV documentation tasks.
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Course content
13 sections • 47 lectures • 4h 43m total length
Requirements
- Basic understanding of pharmacovigilance, drug safety, clinical research, or regulatory affairs is helpful but not required.
- No prior aggregate reporting experience is required. The course explains key concepts step by step.
- Interest in PSUR, PBRER, DSUR, PADER, signal detection, benefit-risk evaluation, or PV career development.
Description
This course contains the use of artificial intelligence.
Welcome to SafeMeds Academy.
This course is a practical, career-focused training program on pharmacovigilance aggregate reporting, covering PBRER, DSUR, PADER, PSUR, signal detection, benefit-risk evaluation, safety summaries, quality control, inspection readiness, and responsible AI-supported pharmacovigilance workflows.
The course is designed to help learners understand how aggregate safety reports are used in real pharmacovigilance and regulatory environments. You will learn how periodic reports connect cumulative safety data, medical interpretation, regulatory expectations, and defensible benefit-risk conclusions.
Throughout the course, you will explore key data sources used in aggregate reporting, including ICSRs, line listings, summary tabulations, literature, clinical trial data, post-marketing data, exposure data, regulatory actions, label changes, and safety commitments.
You will also learn how to review safety information for signals, emerging safety issues, important risks, and practical follow-up actions. The course includes workflows for preparing and reviewing aggregate reports, including PBRER structure, DSUR and PADER workflows, safety evaluation sections, QC checks, common reporting errors, inspection readiness, and finalization.
Because pharmacovigilance is evolving, the course also introduces the responsible use of AI in aggregate reporting. This includes AI-supported summaries, literature review, trend detection, prompting, traceability, hallucination risk, and human oversight.
By the end of the course, you will have a stronger practical understanding of aggregate reporting and how to approach PBRER, DSUR, PADER, PSUR, signals, benefit-risk evaluation, and safety documentation with more confidence.
Who this course is for:
- Pharmacovigilance, drug safety, clinical research, regulatory affairs, and medical writing learners who want practical aggregate reporting skills.
- PV associates, case processors, safety specialists, students, and job seekers preparing for aggregate reporting or signal-related roles.
- Professionals who want to understand PBRER, DSUR, PADER, PSUR, benefit-risk, safety summaries, and AI-supported PV workflows.