Pharmacovigilance

A practical industry approach

There is an increasing demand in the pharmaceutical and biotech industries for qualified pharmacovigilance professionals and access to up-to-date pharmacovigilance training. Our courses in this area are designed to meet this demand, offering you a specialized understanding of pharmacovigilance issues based on a practical industry approach.

Pharmacovigilance training

You can take individual courses or engage in a flexible, part-time postgraduate programme. Eight individual pharmacovigilance courses cover key stages of a drug’s lifecycle and aim to satisfy the educational needs of practicing pharmacovigilance professionals.

Experience

Our diploma modules require a minimum of 2 years of experience in pharmacovigilance or another relevant area, or experience in the pharmaceutical/biological area that qualifies you to benefit from the training. We consider applicants with less than two years of experience on a case-by-case basis.

Introductory courses

Introduction to Drug Safety & Pharmacovigilance

Individual Case Safety Reports (ICSRs) - from Narrative Writing to Causality Assessment

Diplomas (may be taken as individual modules)

Principles of Pharmacovigilance

Pharmacovigilance Systems Master File

Post-Marketing Surveillance

Pre-Clinical and Clinical Aspects of Pharmacovigilance

Pharmacovigilance Data in Application and Registration

Adverse Drug Reactions by Body Systems

Pharmacoepidemiology and Post-Authorisation Safety Studies

Big data, AI, and machine learning in drug safety

Signal Detection and Risk Management

Design your own diploma 

Through our pharmacovigilance department, you can design your own diploma. You can attend individual courses in random order in a way that suits your home or work life. To earn the Diploma in Pharmacovigilance, you must pass five courses, one of which may include a course from the regulatory affairs diploma.

Courses in collaboration with experts

Our pharmacovigilance training courses have been developed as a collaboration between a team of internationally renowned pharmacovigilance experts from the pharmaceutical and biotech industries, the Danish Medicines Agency and researchers from the Faculty of Pharmaceutical Sciences, University of Copenhagen. Through their representation in the Steering Committee and as frequent course leaders and lecturers in the individual modules, all these experts are involved in the continuous development of the programme to ensure its relevance for you.

Advisory board

At Atrium we believe it is of the utmost importance that stakeholders from the entire Life Science sector, being in contact with clinical research one way or another, also represent Atrium’s professional anchor. Here you can see the members of our Pharmacovigilance advisory board:

Karsten Lollike, Corporate Vice President & QPPV, Global Safety Management, Novo Nordisk AS

Marie Banghøj Rosendahl,  Senior Manager Pharmacovigilance, Team Lead at Pharmalex Denmark A/S

Marie Louise Schougaard Christiansen, Lægemiddelstyrelsen

Morten Andersen, Professor in Pharmacovigilance, Department of Medicine and Pharmacology, Copenhagen University

Mette Philipsen, Country Safety Lead, Pfizer Denmark

Janne Malene Kampman, EU QPPV, Senior Director, GPV Safety Surveillance, H. Lundbeck A   

Karen Holm, Medical Information and Pharmacovigilance Manager, Sanofi

Lene Holdrup, Senior Director, QPPV, Global Pharmacovigilance, Ferring Pharmaceuticals A/S

Jesper Hallas, Professor in Clinical Pharmacology, University of Southern Denmark

Ellen Ravn Englev, Director, Case Management Department, Safety Operations, Novo Nordisk A/S

Anette Kirstine Stark, Chief Medical Officer M.D., Ph.D., Danish Medicines Agency

Pilar Carreo, Vice President Global Safety , LEO Pharma

Inge Jeding-Jansen, Senior Director Global Pharmacovigilance, ALK