QPPV, local QPPV and named safety contact
QPPV (Qualified Person Responsible for Pharmacovigilance)
Within the EU, each marketing authorisation holder (MAH) of human or herbal medicinal products must have at their disposal a single point of contact, with a deputy, who is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV). The QPPV must be experienced in all aspects of pharmacovigilance and reside and work within the European Economic Area (EEA).
A comprehensive pharmacovigilance system requires fluent communication between stakeholders, good interaction between processes, a robust quality management system with record management and efficient, proactive oversight by an experienced QPPV. With Medfiles’ competent QPPVs and deputy QPPVs, you can be sure that your pharmacovigilance system fulfils the requirements of Directive 2001/83/EC and the Good Vigilance Practice (GVP) guidelines. In addition to QPPV services, you can also outsource the set-up and maintenance of the entire pharmacovigilance system or just some of your pharmacovigilance activities to Medfiles.
Our QPPVs have range of experience as safety experts with additional training on quality assurance, data integrity and data validation.
Local QPPV and Local safety contact
While the requirements and responsibilities of an EU QPPV are specified in the EU legislation, local QPPVs and safety contacts are subject to the national legislation in each country. When you need qualified and experienced local QPPVs and safety contacts in the applicable European territories, including the UK, we can help you with our extensive regulatory and pharmacovigilance partner network. The selected partners are qualified and audited by Medfiles’ vendor management operations.
Through Medfiles, communicating with the national competent authorities is easy, and Medfiles’ experts are happy to advice you on local pharmacovigilance requirements. By continuously monitoring local regulations, our experts are always up to date with the current legislation and any upcoming changes.
Pharmacovigilance team leaders
Satu Kujala
Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
Saara Mikkola
Head of Operations, Pharmacovigilance, EU QPPV
Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.
Saara has a master’s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.
She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.
