Free guide

Drug Safety & Pharmacovigilance guide

Every Drug Safety & Pharmacovigilance program at Regulated Science Institute in one place: who each program is for, what you will learn and how long it takes.

2 programs
26 hours of study
PDF to keep

How to use this guide

Start with the program closest to your current role, then add the ones your next role asks for. Each entry below lists who the program is written for and the skills you leave with, so you can compare them side by side. Every program ends with a digital certificate of completion you can add to LinkedIn.

Drug Safety and ICSR Case Management Certificate Program

About 12 hours · online, self-paced · certificate

Who it is for

Life-science graduates, nurses, and pharmacy or healthcare professionals seeking entry-level drug safety associate roles.

What you will learn

Determine whether a report is a valid ICSR
Assess seriousness, expectedness, and causality
Code events and drugs accurately
Write a clear case narrative
Meet expedited reporting timelines in the US and EU

Pharmacovigilance Signal Detection and Risk Management Professional Certificate

About 14 hours · online, self-paced · certificate

Who it is for

Drug safety associates and PV professionals ready to move into signal management, aggregate reporting, or PV scientist roles.

What you will learn

Run a signal through detection, validation, and assessment
Interpret disproportionality statistics and their limits
Contribute to PBRER and DSUR authoring
Outline an EU RMP and a US REMS
Present a benefit-risk recommendation to a safety committee

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See the Drug Safety & Pharmacovigilance programs