Ewa Tomerska-Kowalczyk, Director, Safety Operations, has over 15 years’ experience in pharmacovigilance and materiovigilance both pre- and post-marketing. She is familiar with global (European and US) PV regulations and local drug and device safety requirements. Her therapeutic experience includes cardiovascular, analgesia, dermatology, endocrinology, hematology, gastroenterology, oncology, psychiatry, respiratory and rare diseases.

Ewa acts as the subject matter expert for Eudravigilance registration, products entry, and safety reporting, providing Eudravigilance Responsible Person Role for clients. She also works as EU Qualified Person Responsible for Pharmacovigilance (QPV) fin assigned projects, supporting clients in setting up and maintaining processes and documentation required for the Pharmacovigilance system.

Prior to joining Premier Research, she worked as the Qualified Person Responsible for PV (QPPV) in several pharmaceutical companies being accountable for the surveillance of several PV systems in Europe and outside Europe. Furthermore, she was responsible for medical device incident analysis, assessment and reporting. Ewa has Master’s degree in Pharmacy and PhD in Pharmacy from the Jagiellonian University in Cracow, Poland.