Veera Kumpulainen works as a Safety Manager in the Pharmacovigilance Unit at Medfiles. Veera joined Medfiles in 2020 as a Drug Safety Expert and her responsibilities have included a variety of safety related tasks.
Veera holds a Master’s in Molecular Medicine and Cancer Research and a Bachelor’s in Biomedical Science from Brunel University of London. Prior to Medfiles, Veera gained experience in the Global Patient Safety department of a Big 5 Pharma in the UK. She has extensive case processing experience in range of therapeutic areas, with a primary focus on oncology. She currently acts as the Medfiles EU dQPPV and is responsible for the oversight and training of the ICSR case processing team.
ICSR Handling – a PV essential
In her current role, Veera leads the ICSR case processing team at Medfiles. She is responsible for final decisions regarding ICSR management, providing guidance to case processors with her years of knowledge to find solutions to tricky cases.
Regulatory requirements between post-marketing and clinical trial cases differ, and therefore it is important for case processing training to reflect this. Veera is actively involved in the management, creation and training of Medfiles’ personnel in case processing training programs for post-marketing and clinical trials. In addition, Veera often provides consultation to clients regarding case processing and management.
“Medfiles has a team of experienced safety experts and in-house safety physicians responsible for case processing based in the European Union. They provide long-term service and support to our clients.”
Post-Marketing ICSRs
The Guideline on Good Pharmacovigilance Practices Module VI and EU Directives and Regulations are the cornerstones of case processing within the EU and are commonly reflected in other regions in their own pharmacovigilance regulations.
“Post-marketing reports can be received through a variety of solicited and unsolicited sources. This can change their complexity. Consumers often have different levels of medical knowledge compared to HCPs and study investigators, and therefore this impacts the language that they use. This may cause challenges in LLTs MedDRA coding due to differences in reported terms, and the language of follow-up correspondence required.”
Clinical Trial Cases
Strict adherence to Clinical Trial Regulation, ICH GCP, and the company’s Safety Management Plans and SOPs and timeline compliance is required in Phase I-III safety monitoring.
Clinical trial case processing involves management of Serious Adverse Events, Events of Special Interest and SUSARs, from the initial receipt of the case to submission to Regulatory Authorities, as required. The expected volume of SAE and SUSAR reports can drastically differ depending on the IMP, therapeutic area and study phase. In addition, any licencing/business partner agreements may have additional reporting requirements with different timelines, thus causing pressure to the case processing team.
“Whilst I have handled and overseen cases across multiple different therapeutic areas, I have always been most involved in oncology trials. This has allowed me to continue my interest in cancer research from my study during my Master’s degree, to gaining industry experience and through to my years at Medfiles.”
In addition to leading the ICSR case processing team, Veera is the Deputy Qualified Person responsible for Pharmacovigilance (EU dQPPV) at Medfiles. Her work supports global PV systems to ensure the safety profile of products is maintained.
Fantastic Work-Life Balance
Veera enjoys working with internal and external stakeholders, both inside and out of pharmacovigilance. She likes the fast-paced and complex environment of pharmacovigilance, working in both post-marketing and clinical trials.
“I moved from the UK to join Medfiles in Finland in 2020. Since moving, I have enjoyed Medfiles’ flexible working environment, work-life balance and remote working opportunities.”
“Our pharmacovigilance unit is filled with positive and supportive colleagues. An exchange of knowledge is only ever a short conversation away, but we also value the opportunities to relax during a shared coffee break.”
Do you need help with your safety reports? Medfiles provides an EU based case processing service with in-house safety physicians and a validated safety database. Our ICSR management process can be tailored to your needs, from receiving and forwarding reports to complete case processing, including submissions to the competent authorities in the EU/EEA, UK, USA and Canada.
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