“In five years' time, we will be in a very different reality than we are today”

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Katarzyna Lozak is Teva’s Pharmacovigilance (PV) Director for Italy, Bulgaria, Greece and Central and South Eastern Europe. She shares her insights on working in the important area of pharmacovigilance and patient safety. The role of pharmacovigilance is to protect patients and the public and share knowledge among the relevant professional communities.

My adventure with Teva started in 2016 as the PV Manager responsible for the Polish market. After more than four years, I now work right across central and southern Europe.

As a director, I’m responsible for motivating my employees to deliver results. As a pharmacovigilance director, those results are not measured in monetary terms but in terms of compliance. My main job is to anticipate what kind of risks might arise in the countries I work in – and how I can proactively prevent them.

Thirteen countries report to me directly and an additional five indirectly. Officially we deal with 17 different languages. Our team across the region comprises a total of 23 people.

Part of my job is keeping my team motivated and happy in their roles, and also developing and training new colleagues, supporting them until they become independent professionals. PV is a continuous learning process as it is an area that is constantly evolving and has many restrictions. Knowing them, and keeping up to date with the guidelines of the European Medicines Agency (EMA), is essential for dealing proficiently with different situations.

The ideal PV employee is a great analyst who will read many guidelines before expressing an opinion and check facts in many sources before proposing a new solution. They won’t feel an expert after six months on the job, but only after several years and several successfully passed audits. If we have a person who is a great analyst and, additionally, a team player who knows how to motivate others and share knowledge, then we have a real PV talent. Retaining such employees in PV and developing potential candidates is a priority for me.

Most of the countries I work with are European Union member states, so PV legislation is the same and national agencies have only limited prerogatives in the area of Pharmacovigilance, mainly regarding educational materials. However, each country has a slightly different business and PV then locally adapts to the business.

We often need to find a slightly different way of dealing with each country. In Poland, for example, there are a lot of active promotions running in over-the-counter (OTC) medicines, including marketing research, social media, influencers and other projects. As a result, PV had to find answers to a number of questions. Eventually Poland became known as a country that had more PV compliance questions in the OTC marketing area than any other country. Hungarian PV, on the other hand, is very knowledgeable about bioequivalence studies, something we did not deal with directly in Poland. Therefore, it is important to bring together the PV teams that have a similar profile.

Having a regional focus in PV is about knowing which countries have a similar PV profile and bringing staff together so that they can advise each other. Team members will often have to substitute for each other as there are many single-person departments and legal requirements have short deadlines. This means we need to be proficient in local languages so colleagues can successfully provide cover for each other. A PV inspection can come at any time. For me, this regional focus is an opportunity to build a new multicultural team in which everyone feels comfortable and proud of their work.

A challenge I am really looking forward to is working on Teva’s growing and highly diverse portfolio of advanced modern medicinal products, biologics and biosimilars. The increasing digitalisation of healthcare services and the creation of new channels to reach patients is another big area for PV to address. In five years' time, we will all be in a very different reality than we are today.

NPS-ALL-NP-00690 SEPTEMBER 2022


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