Principles of Pharmacovigilance

Understand the principles of pharmacovigilance

1. Feb 2022

3 days course


18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)

Module 1


This course will help you understand the principles of pharmacovigilance, including factors such as Adverse Drug Reactions (ADRs), pharmacovigilance legislation and regulations, the methods used to collect and evaluate adverse drug reactions, preferred communication channels when communicating with authorities and the ethical considerations and implications of pharmacovigilance.

You will be introduced to suspected unexpected serious adverse reactions (SUSARs), individual case safety reports (ICSRs), periodic safety update reports (PSUR) and development safety update reports (DSUR), product safety information and signal detection, quality systems and pharmacovigilance audits and inspections.

The course is offered every 2 years.


  • Pharmacovigilance Legislation
  • Safety Data
  • Post-Authorization Safety Studies (PASS)
  • Risk Management Plans (RMP)
  • Pharmacovigilance Evaluation
  • Pharmacoepidemiology
  • Communication

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Course leader(s) & Lecturers

  • Mette Stie Kallesøe
    Course leader
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S


Whether you are new to the field or have several years of experience, this programme is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.

What you will learn

  1. The principles of pharmacovigilance
  2. How to analyze and evaluate methods and data in drug safety reporting
  3. How to analyze and evaluate regulations and guidelines in pharmacovigilance
  4. Best practices in pharmacovigilance working processes when preparing safety assessments and reports
  5. How to design appropriate pharmacovigilance working methods in a dynamic and changing environment

What your company will get

  1. A safety and pharmacovigilance professional who understands the principles of pharmacovigilance
  2. A safety and pharmacovigilance professional that can independently analyze and evaluate methods and data in drug safety reporting
  3. A safety and pharmacovigilance professional who can analyze and evaluate regulations and guidelines in pharmacovigilance
  4. An employee who can provide valuable input to all other team members involved in pharmacovigilance working processes

Course calendar

Starting 1. Feb 2022
1. Feb 2022 9:00-16:00


  • Overview and introduction to international legislation and organisations
  • History and background of pharmacovigilance EU legislative process
  • Current EU pharmacovigilance legislation and guidance
  • EU Organization: EMA, CHMP, PRAC, CMD(h), National Competent Authorities, Efpia, ICH
2. Feb 2022 9:00-16:00


  • Introduction to pharmacovigilance quality systems, audits and inspections
  • Introduction to the Pharmacovigilance Systems Master File
  • Introduction to safety in clinical trials • Responsibilities of the Qualified Person for Pharmacovigilance (QPPV)
  • Individual Case Safety Reports (ICSRs) and case processing
  • Workshop on Individual Case Safety Reports
3. Feb 2022 9:00-16:00


  • Introduction to Periodic Safety Update Reports (PSURs)
  • Introduction to safety surveillance
  • Introduction to Risk Management Plans (RMP)
  • Introduction to pharmacovigilance related studies
  • Trends and challenges in pharmacovigilance
Practical information

Related exams

4. Mar 2022 9:00-12:00
Go to exam page


Registration deadline
25. Jan 2022
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

Course information


Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus. 


To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in drug safety or pharmacovigilance, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have suitable experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in drug safety or pharmacovigilance. We consider applicants on a case-by-case basis.


The exam takes place online about 4-6 weeks after the course, and you can access it from any location that suits you.

You receive a link with the exam questions via your personal Atrium log-in.

This course is a part of this programme

Pharmacovigilance Diploma

The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Pharmacovigilance Diploma

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Course leader(s)

Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S

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WANT TO KNOW MORE or need help?

Contact Client Manager Ida Salicath at +45 39 15 09 46

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