{"id":7718,"date":"2021-11-12T10:22:57","date_gmt":"2021-11-12T08:22:57","guid":{"rendered":"https:\/\/medfilesgroup.com\/our-services\/pharmacovigilance-vigilance-service%e2%80%8b\/eu-qppv-and-local-qppv-named-safety-contact\/"},"modified":"2026-06-30T13:51:10","modified_gmt":"2026-06-30T10:51:10","slug":"eu-qppv-and-local-qppv-named-safety-contact","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/ja\/our-services\/pharmacovigilance-vigilance-service\/eu-qppv-and-local-qppv-named-safety-contact\/","title":{"rendered":"EU QPPV, local QPPV and named safety contact"},"content":{"rendered":"\n
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EU QPPV, local QPPV and named safety contact<\/h1>\n\n\n\n

QPPV (Qualified Person Responsible for Pharmacovigilance)<\/h2>\n\n\n\n

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).<\/p>\n\n\n\n

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\u2019 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.<\/p>\n\n\n\n

Our QPPVs have range of experience as safety experts with additional training on quality assurance, data integrity and data validation.<\/p>\n\n\n\n

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Local QPPV and Local safety contact<\/h2>\n\n\n\n

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\u2019 vendor management operations.<\/p>\n\n\n\n

Through Medfiles, communicating with the national competent authorities is easy, and Medfiles\u2019 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.<\/p>\n\n\n\n

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other Pharmacovigilance services<\/a><\/div>\n\n\n\n
Veterinary QPPV services<\/a><\/div>\n<\/div>\n\n\n\n
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News and<\/strong> insights on pharmacovigilance<\/strong><\/h2>\n\n\n\n

Our expert team regularly writes blogs on human medicine pharmacovigilance, covering topics such as Regulation 2025\/1466, ICSR case processing and EU QPPV.<\/p>\n\n\n\n

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See all publications<\/a><\/div>\n\n\n\n
Subscribe to medfiles’ newsletter<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n
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Pharmacovigilance team leaders<\/h2>\n\n\n\n
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Satu Kujala<\/strong>
Head of Pharmacovigilance<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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Satu has a Licentiate\u2019s 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.<\/p>\n\n\n\n

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Saara Mikkola
<\/strong>Head of Operations, Pharmacovigilance, EU QPPV<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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Saara has a master\u2019s 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.<\/p>\n\n\n\n

She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.<\/p>\n\n\n\n

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Meet our people:<\/strong> EU QPPV ENSURES DRUG SAFETY ACROSS EUROPE<\/strong><\/h2>\n\n\n\n

Saara Mikkola<\/strong>, Qualified Person responsible for Pharmacovigilance (EU QPPV), plays a crucial role in ensuring the safety of medicinal products within the EU. Saara outlines the main areas of her work as follows:<\/p>\n\n\n\n

\u201cThis role encompasses three primary areas: establishing an effective pharmacovigilance system, thoroughly understanding the safety profiles of the medicinal products, and serving as the primary liaison between our company and regulatory authorities.\u201d<\/p>\n\n\n\n

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Read about Saara’s work and expertise<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n