Summary
Join us for a focused three-day course that provides a comprehensive understanding of pharmacovigilance (PV) systems. You'll gain practical insights into regulatory requirements, essential components of pharmacovigilance systems, and how organisational structure, processes, training, and quality frameworks work together to create and maintain an effective PV system.
You will also learn about essential processes and procedures, IT Systems relevant to PV, and methods for monitoring system performance through internal and external controls. The course covers approaches to preparing for and following up on audits and inspections.
This practical programme will equip you with the knowledge and tools to operate effectively in a highly dynamic PV environment.
We offer this course every two years to ensure content remains current with industry developments.
Keywords
- Pharmacovigilance Systems
- Pharmacovigilance System Master File
- PV Quality Management System
- PV System Key Performance Indicators
- Standard Operating Procedures
- Qualified Person for Pharmacovigilance (QPPV)
- Pharmacovigilance Agreements
- Inspections and Audit
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Course leader & lecturers
- Heidi Filtenborg MadsenCourse leaderLead Specialist, Global Patient Safety
H. Lundbeck A/S - Wasim AnwarCourse leaderVice President & Deputy QPPV, Global Safety
Novo Nordisk A/S - Berit Nautrup AndersenLecturerSafety Director
Link Medical Research, filial af Link Medical Research AS, Norge - Noha KassemLecturerSenior Director
Eli Lilly, United Kingdom - Anna Carina Wiborg SimonsenLecturerPrincipal Specialist, GCP and PV Lead Auditor
Novo Nordisk A/S - Trine BøttzauwLecturerGS Compliance Principal Specialist
Novo Nordisk A/S - Pernille JensenLecturerSenior Safety PV Compliance Professional
Novo Nordisk A/S - Gitte EiersholtLecturerPSMF consultant
- - Mette Stie KallesøeLecturerHead of Pharmacovigilance QPPV
Hansa Biopharma AB
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Is this course for you?
This course is designed for both newcomers and experienced professionals in pharmacovigilance. It provides a structured approach to understanding PV systems, helping you build on existing knowledge while developing new competencies in establishing and maintaining effective pharmacovigilance programmes.
What you will learn
- Core components of pharmacovigilance systems
- The organisation of a pharmacovigilance department and its integration with other departments.
- PV System performance monitoring and implementation of Key Performance Indicators
- Internal and external control measures to maintain an effective PV System, including preparation for PV audits and GVP inspections
- Principles of PV Quality Management Systems
- Structure and content of Pharmacovigilance System Master File (PSMF)
- Principles of designing PV training and competence for the whole organisation
What your company will get
- A safety and pharmacovigilance professional who understands the principles of pharmacovigilance systems and can contribute to the effective performance of PV systems that ensure patient safety
2. A team member who can analyse and evaluate PV regulations and guidelines to determine their impact on pharmacovigilance processes.
3. A professional who can play an important role in any team working with pharmacovigilance systems
Course calendar
Day 1
- Introduction to the Pharmacovigilance Systems
- Master File (PSMF) - structure and management
- Local PSMF
- The organizational structure of the marketing authorisation holder
- Workshop
- Computerised systems and databases
- Quality system - procedural documents
- Pharmacovigilance processes
Day 2
- Pharmacovigilance system performance
- Quality system - document and record control
- Quality system - training
Day 3
- Audits and inspections
- Workshop
- Pharmacovigilance agreements
- Annexes
- Qualified Person for Pharmacovigilance (QPPV)
Registration
Registration deadline1 Sep 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
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.
Prerequisites
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.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
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This course is a part of a 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 Diploma in Pharmacovigilance.
Read moreCourse leaders
H. Lundbeck A/S
Novo Nordisk A/S
Lecturers
Link Medical Research, filial af Link Medical Research AS, Norge
Eli Lilly, United Kingdom
Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk A/S
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Hansa Biopharma AB
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6 Oct 2025
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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