Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Susanna Heinonen, Senior Pharmacovigilance Consultant, QPPV office | EU/UK QPPV
What do you do at ProPharma?
I am working in ProPharma’s QPPV office Team as a Senior Pharmacovigilance Consultant. I am EU/UK QPPV for one of our global customers but also working in some other customer projects. The main responsibilities of the QPPV are the establishment and maintenance of the marketing authorization holder’s PV System and to have oversight on the safety profiles of the medicinal products.
What do you like best about working with clients?
The versatility of working with customers is rewarding. As a consultant you have a great opportunity to learn, not only from your own colleagues at ProPharma but also from your colleagues at client companies. When working with different clients you grow your network, receive experience from different PV systems, setups and gain more practice on audits and inspections.
What is your number one focus right now?
Lately I have been working with additional risk minimization measures,. but especially my focus has been on how to evaluate the effectiveness of the risk minimization measures. I have had my eye on the GVP M XVI (Rev.3) Addendum II (Methods for effectiveness evaluation), which was adopted by PRAC via written procedure on April 9, 2024. Future steps following the update include further consultation at the level of other committees, interaction with the EC, and adoption by HMA’s EU Network Pharmacovigilance Oversight Group (EU-POG) aiming of final document publication by Q2 2024.
Tell us about a day in the life of a EU/UK QPPV.
Apart from PV system oversight, the QPPV consults the marketing authorization holder on commitments towards health authorities, Risk Management Plans, risk minimizsation activities, Safety Data Exchange Agreements, Post Authorisation Safety Studies, and much more. There are always some PBRERs, SOPs or compliance reports to review or approve. Daily QPPV also has correspondence with the LPPV network. The QPPV works in different cross-functional teams and attends many meetings to keep up with the current issues within different topics relating to the PV system and the products.
What's one thing you’d like for potential clients to know about ProPharma?
Despite having a specific expert working with the client, there is actually a huge expert team with different expertise areas and backgrounds behind them. Colleagues are benchmarking from each other, and sharing knowledge and industry’s best practices. Having such versatile expertise available and a global network facilitates outsourcing, because the services needed in our field can be obtained from the same place.
