Master the Fundamentals of Drug Safety & Pharmacovigilance

Name: Master the Fundamentals of Drug Safety & Pharmacovigilance
Rating: 4.4 (326 reviews)

Case Intake, Case Processing, Signal Detection, Regulatory Aspects, Audits and Inspections, Interview Tips and many more

Created byBharadwaja Choudhury

Last updated 8/2025

English

What you'll learn

Pharmacovigilance Overview and Foundational Concepts
Regulatory organizations: EMA, FDA, UMC, ICH, and CIOMS
Case Triage, Case Processing, and Case Management Concepts
Risk Management
Signal Detection
Audits and Inspections
GDPR and HIPAA Regulations
PSMF
Interview Tips and Tricks
History of Pharmacovigilance and Drug Safety
Regulatory Organizations and their role in making drugs safer
Explore the importance of Pharmacovigilance for a pharma Company
Aggregated Reporting
Expedited Reporting
Drug Labelling
Safety Data Exchange
Computer Systems in Pharmacovigilance
Technology in Pharmacovigilance
Real-World Evidence (RWE)
Drug Quality Issues
Future of Pharmacovigilance

Course content

7 sections • 62 lectures • 3h 18m total length

Why are we here?1:04
Patient Safety, Drug Safety and Pharmacovigilance - Making the drugs safer
Your Instructor - Bharadwaja Choudhury1:04
About the instructor.
Careers in Pharmacovigilance2:45
Career Opportunities in Pharmacovigilance and Drug Safety
The Course Design - Why you should enrol for it?4:13
This video talks about the course design, the intended audience and the reason you should enrol for it.
Walkthrough of Course on the Udemy Platform6:20
Walkthrough of the course on Udemy Platform
Journey of a Drug2:54
The journey of a Drug from Discovery to Market
Side Effects of a Drug - Why do they occur in first place?3:06
Why do side effects appear in first place?

Why Pharmacovigilance - Not so glorious past2:31
This talks about the need of Pharmacovigilance in the world of Drugs for Human use. It talks about a few real time scenarios from the past and how they contributed to the evolution of Pharmacovigilance.
Why Pharmacovigilance - Numbers those were expensive1:58
This video talks about the VIOXX withdrawal
Why Pharmacovigilance2:20
Need of Pharmacovigilance in the context of lessons learned from the disasters
What is Pharmacovigilance1:22
This chapter talks about the definition of Pharmacovigilance.
Brain Teasers
Concepts of Adverse Drug Reaction3:34
Preliminary concepts around Adverse Event and Adverse Drug Reaction
Concepts of Adverse Drug Reaction : De-challenge and Re-challenge2:09
Dechallenge and Rechallenge in Pharmacovigilance to perform causality assessment
Be Curious with Curio-CIty0:23
Be Curious - The best approach to learning something new.
Concepts of Adverse Drug Reaction - Concomitance of Drugs2:33
Concomitant medication is when drugs are taken together. Monitoring for concomitant drugs is important from the perspective of managing the safety profile for the drug under surveillance.

Role of Regulatory Organizations4:10
Various Regulatory Organizations and their role in Pharmacovigilance
FDA Regulations - Code of Federal Regulations5:23
Code of Federal Regulations with focus on 21 CFR Part 11 - Important regulations in FDA
Be Curious with Curio-City0:23
Be Curious - The best approach to learning something new.
GDPR - General Data Protection Regulation7:12
The General Data Protection Regulation (GDPR) is legislation that updated and unified data privacy laws across the European Union (EU).
HIPAA Regulations4:32
This chapter talks about an important regulation called HIPAA
HIPAA Vs GDPR3:10
The important difference between HIPAA and GDPR
Brain Teasers
Other Organizations: ICH - Harmonisation for better health3:14
This chapter talks about the role of ICH for Pharmaceuticals and Pharmacovigilance.
Be Curious with Curio-City0:25
Be Curious - The best approach to learning something new.
Other Organizations: Uppsala Monitoring Centre (UMC)4:29
This chapter talks about Uppsala Monitoring Center (UMC) and its role in Pharmacovigilance
Other Organizations : CIOMS2:38
This chapter provides an overview of CIOMS Organization and its objectives in Pharmacovigilance.
Take the Challenge - Maximize Your Learning0:55
Take the Challenge & Maximize your Learning. This exercise will help you collect all your thoughts and understandings of the subject

Source of Adverse Events5:18
Various sources of adverse events and how they reach the Safety database through designated channels
What goes into a Case or ICSR4:18
This chapter talks about the elements that constitute a case record in the safety database. An ICSR as a document for collecting safety information goes into the safety database as a case and managed there.
Case Triage3:09
Case Triaging activity to prepare for the case to be further processed.
Key Concepts - Case Processing8:54
Various concepts used in Case Processing
WHODD for Drug Name Coding1:48
This explains about drug name coding using WHODD Dictionary maintained by UMC (Uppsala Monitoring Centre)
Brain Teasers
Case Processing2:20
Case Processing steps from Data Entry to Case Locking.
Suggested Reading - Case Processing1:17
Case processing further explained.
Aggregate Reporting6:47
The cumulative reporting activity including PSURs, DSURs and PADER
Expedited Reporting1:37
Brain Teasers
Signal Management3:36
Talks about Signal Management Process and It's importance in Pharmacovigilance
Suggested Reading2:06
Further reading on Signal Detection and Management
Risk Management3:43
Role of Risk Management in Risk-Benefit analysis and monitoring process of FDA and EMA
Exchange of Safety Data4:04
This chapter talks about exchange of safety data with partners, stakeholders and agencies
Drug Labeling for Pharmacovigilance5:35
Product Labeling or Drug Labeling in Pharmacovigilance. This chapter talks about the fundamentals of Drug Labeling and its significance in Pharmacovigilance and Drug Safety.
Take the Challenge - Maximize your Learning0:59
Take the Challenge & Maximise your Learning

Drug Safety within Pharma Organization5:02
This chapter talks about Large-scale to medium-scale pharma companies and also about the Generic Companies and CROs that need a Drug Safety function.
Top Pharma Companies1:04
This chapter lists the reading of top Pharma companies, top generic companies, and top CROs in the world.
Pharmacovigilance Organization6:28
Drug Safety Organization and their function
Audits and Inspections4:26
It talks about the importance of Audit/Inspection process
Challenges in Pharmacovigilance3:31
This video talks about various challenges in the PV domain
Be Curious with Curio-City0:24
Be Curious - The best approach to learning something new.
Computer Systems in Pharmacovigilance5:52
This chapter talks about the computer systems in Pharmacovigilance Operations.
Technology in Pharmacovigilance6:41
Technology in Pharmacovigilance finding new ways of Operations. It could be core technologies to manage transactional systems or advanced technology to bring transformation to the Organization.
The PSMF3:09
It talks about the Pharmacovigilance System Master File
From Instructor's Desk - The Learning Path1:44
The Learning Path Forward - From Instructor's Desk

The Future of Pharmacovigilance5:00
The future of Pharmacovigilance talks about a few factors that can change the course of Pharmacovigilance in a favorable way for the patients and making drugs safer.
Safety in Clinical Trial Phases3:01
This video talks about capturing Safety events during Clinical Trial Phases
Real World Evidence3:39
This chapter talks about Real World Data and Real World Evidence and benefits.
Drug Quality Issues4:06
This video talks about drug quality issues and measures to address drug quality issues
Take the Challenge - Maximize your Learning1:02
Take the challenge to maximise your learning.

The Final Frontier - Test Your Learning
Assignment Challenge - 1
Interview Questions - Basic Level2:47
This video contains basic level interview questions.
Interview Questions - Behavioral5:46
This lesson talks about personality and behavioral interview questions
From Instructor's Desk - Preparing for Interview2:18
Interview Questions Advanced
PROMOTION - Mastering Computer Systems - Reference to Argus0:28
Mastering Computer Systems in Pharmacovigilance with reference to Oracle Argus Safety
PROMOTION - Generative AI in Pharmacovigilance1:10
Promotion - Take your career to new heights by learning "Generative AI for Pharmacovigilance and Drug Safety Operations". This course is published on Udemy platform.
Thank You0:54
Thank you and wish a great career ahead.

Requirements

No programming or technology experience needed
Interested to build career in Pharmacovigilance Domain

Description

Students have been loving this tutorial—which is evident from the fantastic course ratings—and you will too!

If you’ve ever wanted to understand how the world of drug safety works, or if you’re preparing to step into a pharmacovigilance career with confidence, this course gives you everything you need in one engaging, easy-to-follow package.

This tutorial is designed for beginners, aspiring professionals, and anyone curious about the science and systems that keep medicines safe. Instead of overwhelming you with definitions and regulations, this course breaks down complex concepts into simple, relatable explanations, real-world examples, and practical insights you can immediately apply.

From foundational topics like case triage, processing, causality assessment, and seriousness assessment, to more advanced subjects like signal detection, risk management, aggregated and expedited reporting, drug labelling, and the Pharmacovigilance System Master File (PSMF)—this tutorial provides a complete and holistic overview. You’ll even learn about GDPR and HIPAA, drug quality issues, and how technology is transforming the way safety systems operate.

You’ll journey through the history of pharmacovigilance, understand how it evolved, and explore what the future holds as technology, AI, and real-world evidence reshape the industry. You’ll also gain clarity on the global regulatory ecosystem—including the EMA, FDA, UMC, ICH, and CIOMS—and how these organizations work together to ensure patient safety worldwide.

What makes this course truly unique is its human touch. You won’t just learn what pharmacovigilance is—you’ll understand why it matters. You’ll see how critical PV is for pharma companies, public health, and patient trust. Plus, to keep learning fun and interactive, the tutorial includes quizzes, exercises, and interview tips and tricks for those aiming to break into or grow within the industry.

Past students describe this course as truly foundational, easily understandable, and surprisingly enjoyable. Now it’s your turn.

If you're ready to build confidence, gain clarity, and explore a fulfilling career in drug safety, enrol today and join thousands of learners who have already benefited from this comprehensive and motivating introduction to pharmacovigilance!

Please note that this course is theoretical in nature and for educational purpose only. This provides a path for you to explore the subject further. The real time scenarios in your Organization can be very much different. Kindly take cognizance and perform due diligence while applying any of the concepts, directly in your workplace. Thank you and Happy Learning.

Who this course is for:

Anyone in Pharmaceutical or Healthcare Industry
Professionals in Patient Safety or Drug Safety Organization
IT Professionals working in Patient Safety or Pharmacovigilance domain projects
Pharmacy Students

Master the Fundamentals of Drug Safety & Pharmacovigilance

What you'll learn

Explore related topics

Course content

First things first7 lectures • 21min

Introduction to Drug Safety and Important Concepts8 lectures • 17min

Regulatory Aspects of Pharmacovigilance11 lectures • 37min

Core Pharmacovigilance Activities15 lectures • 56min

The Supporting Ecosystem10 lectures • 38min

Advanced Topics5 lectures • 17min

Concluding Sessions6 lectures • 13min

Requirements

Description

Who this course is for: