Pharmacovigilance for Beginners and Stakeholders 

Pharmacovigilance plays a vital role in protecting patient safety and ensuring the success of medicinal products, across development, approval, and beyond. As regulatory expectations grow, so does the need for professionals across all functions to understand how safety data is collected, evaluated, and monitored.

Through accessible and engaging sessions, this course offers a practical foundation in pharmacovigilance. Participants will understand the history of pharmacovigilance, explore the key principles and regulations, and learn how safety is managed throughout a product’s lifecycle, from early development to post-marketing. Participants will also understand the essential terminology, such safety signals and adverse events as well as sources of adverse event reports, evaluation and assessment of adverse event reports, and quality requirements within the pharmacovigilance area.

This course will focus on the rules and regulations set by the European Union (EU). 

Pharma IT Academy uses innovative teaching methods, including a case handling exercise that provides hands-on experience in evaluating an adverse event report. The course also includes interactive lectures and discussions to facilitate learning and engagement.   

Additionally, the course material is presented in an easy-to-understand format that is accessible to all participants.   

About Instructors 

Jasmin Yousefi is a Pharmacovigilance Consultant with over 8 years of experience in safety surveillance across the drug development lifecycle, from clinical trials (Phase I-IV) to post-marketing. Her expertise includes medical evaluation, aggregate reporting, signal detection, benefit-risk assessments, and the development of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Jasmin has contributed to clinical trial documents such as protocols, investigator’s brochures, and clinical study reports. She has also served as Chairperson for Safety Committees (SCs) and Data Monitoring Committees (DMCs). With extensive experience in regulatory interactions and label updates, Jasmin offers a comprehensive approach to managing drug safety.

Mie Sørensen is a Pharmacovigilance Consultant with over 10 years of experience in the pharmaceutical industry, covering the entire drug lifecycle from clinical trials to post-marketing surveillance. Expertise includes case processing, medical review and assessment, company comment preparation, health hazard evaluations, signal detection, and the development of aggregate reports such as DSURs and PSURs. Experience spans roles at both affiliate and headquarters levels, combining a deep understanding of local and global pharmacovigilance operations with the ability to navigate complex regulatory environments.  

Participants will leave this course having:  

•  A clear overview of pharmacovigilance and its purpose           

•  Insight into stakeholder responsibilities across departments    

•  Knowledge of regulatory requirements and safety reporting         

• Hands-on experience through a practical case-handling exercise       

•  Tools to better collaborate with PV teams and contribute to product safety 
   

Who should participate?  This introductory course is ideal for beginners in pharmacovigilance or individuals looking to explore this field. It's especially relevant for anyone who works alongside pharmacovigilance teams, including professionals in clinical research, regulatory affairs, quality assurance, medical affairs, IT, legal, or commercial roles. No prior experience or knowledge in pharmacovigilance is required. 

Logistics: The course is held in person and the duration is one day, from 9 AM to 4 PM. The course will be held in person at Pharma IT's office in Copenhagen (Skelbækgade 2, 1717 København). 
 

Your purchase includes: 

• Meeting materials 

• Breakfast, lunch & afternoon snack 

• Certificate of course completion 

• 1-year free membership to the Pharma IT Network