10 years of pharmacovigilance experience combined with quality management expertise

Arda Sanaktekin

Arda Sanaktekin works as a Drug Safety Expert in Medfiles’ Pharmacovigilance Unit, bringing nearly 20 years of experience in the pharmaceutical industry, including almost 10 years in pharmacovigilance. Arda holds a pharmacy degree from Marmara University in Turkey and a master’s degree in toxicology from the University of Eastern Finland. Her broad experience in pharmacovigilance and quality management supports her daily work in drug safety.

Arda began her career in 2007 as a responsible manager at a pharmaceutical warehouse, where she gained experience in quality management and GxP principles. She later established her own pharmacy, gaining valuable experience in customer interaction, sales and people management.

However, her main interest remained in the pharmaceutical industry, and in 2014, she transitioned to pharmacovigilance. Since then, she has worked for international pharmaceutical companies in various pharmacovigilance roles.

What interests me about pharmacovigilance is how it connects with so many different functions within a pharmaceutical company and offers opportunities for continuous professional development.

At Medfiles, Arda’s main responsibilities include PV intelligence monitoring and vendor oversight. She also works with global literature monitoring, PV agreement and standard operating procedure (SOP) management. In addition, she has participated in PV audits as part of her ongoing auditor qualification. In 2026, she also became qualified in individual case safety report (ICSR) management for both post-marketing and clinical cases.

Her previous experience covers a wide range of pharmacovigilance activities, including case management, literature review, medical information, market research studies, risk management, audits and vendor management. Through PV agreement management, she has also gained experience in business development and product launch activities. In addition, she has worked in quality management, including SOP management, training management and quality audits.

One of Arda’s key strengths is her dedication to process improvement. She enjoys analysing existing processes, identifying opportunities for improvement and developing practical solutions. Her ability to learn quickly also helps her adapt to new responsibilities and different client needs.

Arda’s decision to move to Finland was partly influenced by the country’s highly regarded education system and her wish to provide good educational opportunities for her child. After moving to Finland, she pursued a long-standing ambition of completing a master’s degree in toxicology to deepen her knowledge relevant to pharmacovigilance. She completed her degree while working part-time at Medfiles and particularly appreciates the flexibility and supportive working environment that allowed her to combine work, studies and family life.

One of the things I appreciate most about working at Medfiles is the flexibility. I was able to complete my master’s degree while continuing to work, with support for both work–life balance and professional development. I am very grateful to work in such a welcoming and supportive environment.

For Arda, continuous professional development and improving pharmacovigilance processes are important parts of her work. She is motivated by the opportunity to apply her expertise to support clients and contribute to patient safety.

At Medfiles, my goal is to support patient and drug safety by using my expertise to improve how we work and help meet our clients’ needs.

Medfiles offers comprehensive pharmacovigilance services across the EU, UK and US with 20+ years of experience. Whether you need support at headquarters or local level, our experts are happy to help. We will guide you through the entire product lifecycle, from safety profiling in the clinical phase to post-market PV systems. Our services are always tailored to your needs, from comprehensive service packages to individual tasks.

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