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Pharmacovigilance Research & Drug Safety Monitoring
Rating: 3.0 out of 5(1 rating)
7 students

Pharmacovigilance Research & Drug Safety Monitoring

A Complete Guide to Pharmacovigilance Principles, ICSR, Signal Detection, and Regulatory Compliance for Career Growth
Created byJeet Ghosh (BRIT,DRD,CMS,DITA)
Last updated 7/2025
English

What you'll learn

  • The fundamentals and purpose of pharmacovigilance in public health
  • Key components and types of Individual Case Safety Reports (ICSRs)
  • The role of regulatory bodies like FDA, EMA, WHO in drug safety oversight
  • Core principles of signal detection and safety signal evaluation
  • Structure and function of global pharmacovigilance systems and databases
  • Overview of post-marketing surveillance and adverse event reporting
  • Introduction to ICH guidelines, GVP modules, and international compliance standards
  • Risk-benefit analysis and how safety profiles of drugs are monitored over time

Course content

1 section • 10 lectures • 2h 2m total length

  • Lesson 1: Introduction to Pharmacovigilance13:19

    In This Lesson You Will Learn :


    1. Definition and scope of pharmacovigilance

    2. Importance of drug safety in public health

    3. Historical evolution of pharmacovigilance systems

    4. Key objectives and benefits to healthcare

  • Lesson 2 : Adverse Drug Reactions (ADRs) and Terminologies13:41

    In This Lesson You Will Learn :


    1. Understanding ADRs: types and classifications

    2. Difference between ADRs, side effects, and medication errors

    3. Terminologies used in pharmacovigilance (AE, SAE, SUSAR, etc.)

    4. WHO and CIOMS definitions

  • Lesson 3 : Individual Case Safety Reports (ICSRs)13:03

    In This Lesson You Will Learn :


    1. What is an ICSR and its importance in drug safety

    2. Components of an ICSR (narrative, coding, seriousness, outcomes)

    3. Criteria for validity and completeness of a report

    4. Reporting timelines and global submission standards

  • lesson 4 : Global Regulatory Authorities and Frameworks9:11

    In This Lesson You Will Learn :


    1. Overview of key regulators: FDA (USA), EMA (EU), MHRA (UK), CDSCO (India), and WHO

    2. International Conference on Harmonisation (ICH) and its role

    3. Good Pharmacovigilance Practices (GVP) Modules

    4. Regional vs. international reporting standards

  • Lesson 5 : Signal Detection and Risk Management10:14

    In This Lesson You Will Learn :


    1. What is a safety signal and how it is identified

    2. Tools and methods used for signal detection

    3. Introduction to risk-benefit analysis

    4. Role of Risk Management Plans (RMPs)

  • Lesson 6 : Pharmacovigilance Methods and Data Sources12:36

    In This Lesson You Will Learn :


    1. Spontaneous reporting systems (SRS)

    2. Cohort and case-control studies

    3. Electronic health records (EHRs) and databases

    4. Passive vs. active surveillance

  • Lesson 7 : Post-Marketing Surveillance (PMS) & Real-World Evidence understanding13:09

    In This Lesson You Will Learn :


    1. Objectives of post-marketing surveillance

    2. Strategies used for ongoing safety monitoring

    3. Importance of real-world data in pharmacovigilance

    4. Examples of pharmacovigilance failures and recalls

  • Lesson 8 : Safety Reporting Requirements and Compliance13:54

    In This Lesson You Will Learn :


    1. Reporting obligations for sponsors, investigators, and MAHs

    2. Timelines and formats for expedited and periodic reporting

    3. E2E, E2B(R3) and electronic reporting standards

    4. Overview of Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR)

  • Lesson 9 : Ethics, Confidentiality & Quality in Pharmacovigilance12:48

    In This Lesson You Will Learn :


    1. Ethical principles in safety reporting

    2. Data protection and confidentiality of patient information

    3. Importance of quality systems and audits in pharmacovigilance

    4. Good Documentation Practice (GDP)

  • Lesson 10 : The Future of Pharmacovigilance10:27

    In This Lesson You Will Learn :


    1. Emerging trends in pharmacovigilance: AI, automation, and signal analytics

    2. Regulatory technology (RegTech) in drug safety

    3. Challenges and opportunities in global pharmacovigilance

    4. Final revision: Integrating all concepts covered in the course

Requirements

  • No prior experience in pharmacovigilance or drug safety is required
  • A basic understanding of healthcare, pharmacy, life sciences, or clinical research is helpful but not mandatory
  • Curiosity to learn about drug safety regulations, reporting systems, and global compliance frameworks
  • Ability to read and understand academic English used in scientific and regulatory content

Description

Explore the critical world of Pharmacovigilance and Drug Safety Monitoring with this comprehensive and expertly crafted theoretical course. Designed for aspiring professionals and healthcare learners, this course offers a deep and structured understanding of the scientific, regulatory, and ethical framework that underpins drug safety surveillance.

In today’s fast-evolving pharmaceutical and clinical research industries, ensuring drug safety is a top priority. This course explores how adverse drug reactions are identified, assessed, and reported, and how safety data plays a central role in public health protection.

From the fundamentals of pharmacovigilance science to in-depth discussions on regulatory guidelines, ICSR reporting, signal detection, and risk management planning, each topic is clearly explained to help you build a solid academic foundation in this specialized field.

Whether you're preparing for a career in drug safety, aiming to contribute to clinical research organizations, or simply seeking to understand how modern medicine ensures patient safety post-approval, this course delivers powerful insights with clarity and depth.


What You Will Learn

  • Understand the core concepts and purpose of pharmacovigilance

  • Explore the structure and types of Individual Case Safety Reports (ICSRs)

  • Learn how drug safety data is collected, categorized, and managed

  • Discover global regulatory authorities and their roles (FDA, EMA, WHO)

  • Dive into signal detection, benefit-risk evaluation, and safety profiling

  • Review ICH, GVP, and other international pharmacovigilance guidelines

  • Gain insights into risk management planning and post-marketing surveillance


Who This Course Is For

  • Students of pharmacy, medicine, biotechnology, and healthcare

  • Clinical research and drug development professionals

  • Individuals preparing for roles in pharmacovigilance or regulatory affairs

  • Anyone curious about how drug safety systems operate behind the scenes

Enroll now Get Certificate as an professional .

Who this course is for:

  • Anyone curious about how adverse drug reactions are tracked, analyzed, and reported globally
  • Students of pharmacy, medicine, biotechnology, or allied health sciences
  • Professionals in clinical research, regulatory affairs, or healthcare industries seeking foundational knowledge
  • Individuals aspiring to enter the field of pharmacovigilance or drug safety monitoring
  • Medical writers and healthcare analysts interested in understanding drug safety processes

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