Essentials of Pharmacovigilance

Foundational course covering the core components of pharmacovigilance and materiovigilance.

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About this Course

This course provides the basic concepts of pharmacovigilance and materiovigilance, with a focus on the regulatory and practical aspects of postmarket safety science of drugs, biologics, and medical devices. It introduces Individual Case Safety Report (ICSR) generation and processing and explains adverse drug reaction (ADR) reporting. The course describes key safety databases, pharmacovigilance software, aggregate reports, and risk management strategies. Importantly, the course features modules on both U.S. and global pharmacovigilance practices and regulations. The course concludes with two modules on materiovigilance, or the postmarket surveillance and reporting for medical devices, covering both U.S. and international practices and regulations.

Course Preview:

Language Availability: English

Suggested Audiences: Biotechnology Companies, Contract Research Organizations (CROs), Medical Device Manufacturers, Pharmaceutical Manufacturers, Principal Investigators (PIs), Regulatory Affairs Professionals, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

Understanding Drug Safety and Pharmacovigilance

The module introduces the purposes and key practices of pharmacovigilance (PV) and drug safety. It describes the classification of adverse events (AEs) and adverse drug reactions (ADRs) while examining hypothesis generation and confirmation methods used in PV. The module concludes by examining some of the challenges that the fields of PV and drug safety face.

Recommended Use: Required
ID (Language): 21077 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Individual Case Safety Report (ICSR) Processing

This module describes elements of a valid ICSR. It defines the key steps involved in ICSR processing and examines various case scenarios where an ICSR can be generated. It includes a discussion of the Medical Dictionary for Regulatory Activities (MedDRA) and its use for coding ICSRs. The module concludes by detailing the U.S. Food and Drug Administration (FDA) requirements for ICSR submissions.

Recommended Use: Required
ID (Language): 21078 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Postmarket Adverse Drug Reaction (ADR) Reporting

This module describes different sources of adverse event (AE) reports, including those deriving from passive and active surveillance. It examines different adverse drug reaction (ADR) reporting systems and details the U.S. Food and Drug Administration (FDA) requirements for postmarket reporting. Additionally, the module discusses the types and uses of MedWatch forms.

Recommended Use: Required
ID (Language): 21079 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Drug Safety System Technologies

The module describes key safety databases and surveys the evolution of pharmacovigilance software. It explains the advantages of artificial intelligence and machine learning and outlines the implications of systems of intelligence for postmarket surveillance and reporting. The module concludes by exploring the prospects of new technologies in pharmacovigilance.

Recommended Use: Required
ID (Language): 21080 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Periodic Reports and Risk Management

This module explains the format and presentation of different postmarketing aggregate reports. It describes the requirements and timelines for aggregate report submissions. The module also details the contents of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMSs).

Recommended Use: Required
ID (Language): 21081 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Pharmacovigilance Quality Management Systems (QMSs)

The module explains the purpose of a robust pharmacovigilance QMS and describes its key components. It discusses the uses of root cause analysis (RCA), corrective, preventative action plans (CAPAs), and independent auditing. It identifies the responsibilities of those who manage and maintain QMSs. Additionally, it details the international guidelines related to a pharmacovigilance QMS.

Recommended Use: Required
ID (Language): 21082 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

U.S. Food and Drug Administration – Safety Regulations and Guidance

This module examines the FDA’s regulation of marketing authorization holders (MAHs) postmarket behavior. It explains the function of postmarket studies and risk identification and mitigation measures. Additionally, the module describes the kinds of drug safety information communicated to physicians and the general public. It concludes by identifying the actions that the FDA takes when regulations are not followed.

Recommended Use: Required
ID (Language): 21083 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Global Pharmacovigilance Regulations

The module focuses on pharmacovigilance practices and regulations outside of the U.S. It details pharmacovigilance in the European Union, with a focus on the Eurpean Medicines Agency’s (EMA) Good Pharmacovigilance Practices (GVP) guidelines and the EudraVigilance Database. The module surveys postmarket activities in the United Kingdom, Northern Ireland, Australia, Japan, India, China, Singapore, the Middle East, and Latin America.

Recommended Use: Required
ID (Language): 21084 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Materiovigilance in the United States

This module defines materiovigilance and explains its implications for the medical device industry. It describes materiovigilance processes and practices in the U.S., including post-approval studies, reporting requirements, safety databases, user reports, surveillance mechanisms, and risk management activities.

Recommended Use: Supplemental
ID (Language): 21085 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.

Materiovigilance Outside the U.S.

The module turns its focus to postmarket surveillance and regulations of medical devices outside of the U.S. It examines the approaches to materiovigilance in the European Union, India, China, Japan, Australia, and Canada, noting similarities and differences across regulatory systems. The module concludes by exploring global harmonization efforts.

Recommended Use: Supplemental
ID (Language): 21086 (English)
Author(s): Akshita Srivastava, MSc - DDReg Pharma Pvt. Ltd.


Who should take the Essentials of Pharmacovigilance Course?

The course is designed for individuals new to pharmacovigilance or materiovigilance, including undergraduate and graduate students, university faculty and postdocs in the biomedical sciences (such as pharmacy, epidemiology, and biomedical engineering) as well as members of contract research organizations, biotechnology and pharmaceutical companies, and medical device manufacturers. The content is ideal for sponsors looking to onboard new safety officers. The course is also useful for those responsible for interfacing with drug, biologic, or medical device regulators (such as local and national health departments).

How does the Essentials of Pharmacovigilance course complement other CITI Program courses?

Essentials of Pharmacovigilance serves as a helpful complement to CITI Program’s Good Clinical Practice courses and its Clinical Research: An Introduction course. These existing courses provide instruction on safety science during clinical investigations. Essentials of Pharmacovigilance offers a similar introduction to safety science after market approval. Combined, they provide a comprehensive look at how safety is assured for drugs, biologics, and medical devices.

Why should someone take Essentials of Pharmacovigilance course?

Learners who wish to gain a foundational understanding of postmarket surveillance and regulation should take this course to prepare for a career in pharmacovigilance or materiovigilance. Similarly, learners can acquire the necessary knowledge for those roles interfacing with regulators.

This course can be used in onboarding for those new to the field or for those taking on new roles that involve surveillance and regulatory responsibilities.

How long will the course take a learner to complete?

This course consists of ten modules. Each module contains detailed content, a quiz, images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around five to seven hours to finish all ten modules.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the required and supplemental modules for learner groups?

This course is designed to be completed sequentially through the first eight modules (we recommend they are set as “required”). The two following additional modules should be set for “supplemental.” These supplemental modules are recommended for individuals interested in materiovigilance. The supplemental modules provide rich information relevant to materiovigilance but are not essential for the learner to gain a foundational knowledge of pharmacovigilance.


  • Understanding Drug Safety and Pharmacovigilance
  • Individual Case Safety Report (ICSR) Processing
  • Postmarket Adverse Drug Reaction (ADR) Reporting
  • Drug Safety System Technologies
  • Periodic Reports and Risk Management
  • Pharmacovigilance Quality Management Systems (QMSs)
  • S. Food and Drug Administration – Safety Regulations and Guidance
  • Global Pharmacovigilance Regulations


  • Materiovigilance in the United States
  • Materiovigilance Outside the U.S.

What are the advantages of CITI Program's Essentials of Pharmacovigilance course?

This course has several advantages compared to competing training in pharmacovigilance. It is more comprehensive than others, covering postmarket surveillance and reporting of medical devices as well as drugs and biologics. It also focuses on regulations in the U.S. and internationally and includes detailed instruction on pharmacovigilance technologies and databases.

This course provides peer-reviewed training written by pharmacovigilance and materiovigilance experts. CITI Program's advantages, including our experience, customization options, cost-effectiveness, and focus on organizational and learner needs, make it an excellent choice for clinical research training.

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