Bio

A drug and medical device development professional with focus on safety and digital health. My extensive experience is based on being ward physician, field monitor, clinical trial head, research physician, drug safety leader and digital solutions with medical safety focus. Aiming to lead projects to provide physicians with new therapeutical tools with which they could reduce patients burden. Experience in developing medicinal products and medical devices - in cardiovascular and respiratory disease areas - including smart inhalers, patient application, diagnostic softwares, etc. Experience in digital data screening for potential safety signals, innovative solutions around different aspects of medical safety and working in QPPV office. Specialties: - leading safety management team (per CIOMS VII) both in drug and in medical device pre- and post-market phases; focusing on signal evaluation, management and communication - management of big submission studies from study design through execution (project management) till regulatory submissions -- authoring clinical trial protocols, eCRF, study report, SCS, DSUR, PSUR, HA documents, Safety section of labels, etc. - development of innovative (AI based) solutions for drug safety processes - business system owner of IT application - defining new processes to address new HA requirements - development of definitions for digital data screening for potential AEs