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Dr. Iwona Kmicikiewicz, of Kraków Poland obtained her PhD in Biology from Jagiellonian University (Kraków), with specialization in endocrinology. She served in the capacity of a Pharmacovigilance Department Safety Officer and as a local QPPV in a pharmaceutical company with portfolio of over 100 different products registered in over 40 markets for over nine years. She was engaged in the set-up and maintenance of the safety system with SOP development, preparation, training of staff, processing and reporting activities. Since 2000 she has worked as Project Manager mainly responsible for bioequivalence studies.
Since 2004, Dr. Kmicikiewicz has worked in the capacity of Safety Manager and Project Manager in Ergomed. With 18 years of clinical trial experience she has participated in or led a wide variety of phase II – III multi-centre / multi-national clinical research programmes and large scale trials. Starting in 2008, Dr. Kmicikiewicz was key in the set-up of Primevigilance providing for both clinical and post-registration safety services. Since 2011, she has taken the role of Manager of Clinical Operations in Ergomed Krakow office, with responsibility for leading clinical operations in Poland and the related countries. Beginning in 2013, she has served in the capacity of a Head of the Clinical Safety Department, Project Director and Office Director in Ergomed Polish office.