Saara Mikkola is the Head of Operations and the Qualified Person responsible for Pharmacovigilance (EU QPPV) at Medfiles Pharmacovigilance Unit.
Saara holds a Master’s degree in Pharmacy, having graduated from the University of Helsinki, Finland, in 2012. With over a decade of experience in the pharmaceutical industry, she has dedicated her career to various pharmacovigilance tasks. Saara joined the Medfiles Pharmacovigilance team in 2020. Before her current position, she gained valuable experience as a Drug Safety Expert and later as a Safety Manager at Medfiles.
Broad responsibilities as EU QPPV
Saara has been the EU QPPV for Medfiles since December 2023. The QPPV plays a crucial role in ensuring the safety of medicinal products within the EU. The QPPV’s presence is mandatory for all marketing authorisation holders in the EU.
Saara outlines the three main areas of her work:
“As the EU QPPV, I am responsible for all pharmacovigilance activities related to medicinal products within the European Union. This 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.”
1. Establishing an effective pharmacovigilance system
“My primary responsibility is to develop and implement processes that ensure the accurate collection, assessment, and monitoring of all safety data concerning medicinal products. An essential aspect of this responsibility is maintaining the Pharmacovigilance System Master File (PSMF), which provides a comprehensive description of the entire pharmacovigilance system and is crucial for regulatory inspections. This system is essential for identifying potential risks as early as possible and includes ensuring compliance with EU regulations and adapting to new regulatory requirements or scientific advancements.”
2. Understanding the safety profiles of medicinal products
“I oversee the safety of the medicinal products covered by the pharmacovigilance system(s) I am responsible for. This requires a comprehensive and up-to-date understanding of the potential risks associated with these products, including both potential and actual risks, adverse events and interactions with other drugs. It is crucial to continuously evaluate the benefit-risk balance of each product. I ensure that any changes in the safety profile are promptly identified, assessed and that these findings are effectively communicated within the company and to external stakeholders, including regulatory authorities.”
3. Serving as the primary liaison between the company and regulatory authorities
“As the EU QPPV, I am the primary point of contact between the company and regulatory authorities. This role requires maintaining an open, transparent, and consistent line of communication with all relevant health regulatory bodies, such as the European Medicines Agency (EMA). I am responsible for ensuring that all pharmacovigilance-related communications, including reports of adverse reactions, periodic safety updates, and responses to regulatory inquiries, are accurately and promptly submitted in accordance with legal and regulatory standards. Additionally, my position involves advocating for the company’s compliance with pharmacovigilance requirements and negotiating with regulatory authorities to address any concerns related to the safety of the medicines.”
While the EU QPPV is ultimately responsible for the pharmacovigilance system of a marketing authorisation holder, it is important to delegate tasks to ensure efficient and compliant operations. The process involves selecting competent team members based on their qualifications and experience, providing them with the necessary training and resources, and setting up clear communication and reporting structures. The EU QPPV maintains rigorous oversight through regular monitoring and audits, ensuring that all delegated activities meet regulatory standards. Accountability is a crucial element of the process, with each team member clearly responsible for specific tasks. This allows the EU QPPV to oversee and adjust the delegation process to maintain the highest standards of pharmacovigilance practice.
In addition to her role as QPPV, Saara also serves as Head of Operations for the Pharmacovigilance Unit. This entails responsibility for multiple operational tasks and development projects.
“I am responsible for Medfiles’ pharmacovigilance activities for human medicines and our Medical Information Services. I act as one of the supervisors in our team, constantly developing our services and processes. I also undertake a wide range of pharmacovigilance work for our client companies. My primary focus is on post-market pharmacovigilance tasks.”
Wide expertise and a great team
Saara has gained her extensive expertise through a variety of 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 believes her strengths lie in her ability to work effectively in cross-functional teams, collaborate with different stakeholders, and adapt to the ever-evolving pharmacovigilance landscape and technologies.
Saara is pleased to be working at Medfiles and values the clients and the supporting team:
“I am driven by the challenging nature of my work, which involves collaboration with clients and different departments, problem-solving, and continuous learning. Our clients are great, and we work very well with them. Our well-honed processes and ways of working, with the support of both my own team and other departments, allow me to be successful in my job and ensure the quality of the work. The importance of team support cannot be overstated.”
“At Medfiles, I particularly value the flexible working culture and the respectful atmosphere for employees.”
