View all courses

Global Pharmacovigilance Awareness

Global Pharmacovigilance Awareness


Pharmacovigilance is the process of monitoring the efficacy and safety profile of novel medications throughout their use in the healthcare system. The use of these medications in the heterogeneous population and uncontrolled environment will provide information concerning the side effects, adverse reactions, and interactions that could not have been unearthed during the clinical trials. This course includes an introduction to the concept' detailing its history and importance. It also emphasizes the need for global pharmacovigilance.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.








Lesson 1: What is Pharmacovigilance?


  • Origin of Pharmacovigilance
  • Scope of Pharmacovigilance


Lesson 2: Purpose of Pharmacovigilance


Lesson 3: Pharmacovigilance Systems


  • Methods of Pharmacovigilance Systems
  • Spontaneous Reporting
  • Cohort Event Monitoring
  • Targeted Clinical Investigations
  • Comparison of Pharmacovigilance Methods


Lesson 4: Pharmacovigilance Case Processing


  • Data Management
  • Relationship Assessment Between Drug and Adverse Reaction
  • Reporting to Appropriate Bodies


Lesson 5: Achieving Global Pharmacovigilance Awareness


  • National Pharmacovigilance Centers
  • Health Professionals
  • Pharmaceutical Companies
  • Patients and General Public
  • WHO Monitoring Programs
  • Challenges to Achieving Global Pharmacovigilance Awareness









Global Pharmacovigilance Awareness
Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

$150 $150

Buy now

General info:

Duration :



Skill level:




Final exam:


Certificate of Completion:



Global pharmacovigilance awareness is necessary if the pharmaceutical industry will adapt to the needs of consumers continuously with safety and efficacy in view. The team now understands why all nations must contribute their quota to a global data pool and by extension why our team should take pharmacovigilance documentation and reporting seriously.

Regina C


Training Director

$150 $150

Buy now

See a preview of this course

No video yet for this course

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h