Diana Dembinsky

• Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised • Data Entry and Case Assessment (ARISg)

• Data entry of SAE reports (ARGUS) • MedDRA coding • SUSAR submission as line listing

• Revision, preparation, processing and submission of ICSRs (ARGUS) efficiently performed. Follow-up requests (hands-on experience) • Data reconciliation (licence partners and internal departments) • My work contributed to successfully pass the annual audit concerning the pharmacovigilance, quality and medical department

• Revision, preparation and processing of ICSRs (AERS, ARISg), Follow-up requests, Data reconciliation (licence partners and internal departments) • Efficiently supported the process to ensure overall PV compliance • Assisted in putting the documents from the last 10 years in order, which resulted in a successful accomplishment of the Spanish Health Authority (AGEMED) audit after the merge between the companies Casen and Recordati

• Revision, preparation and processing of ICSRs (ARGUS), Follow-up requests • I was actively involved in the development of the business continuity plan of the pharmacovigilance department

• Processing of ICSRs (ARGUS, Clintrace) • Medical Coding (MedDRA, WHODD) • Literature review and quality checks (four-eyes principle) • I contributed to process optimisation that resulted in efficient case processing

Human Reproduction / Embryologist: • Physiology and pathology of human reproduction • Molecular and physiopathological background, epidemiology, diagnostic procedure and treatment of infertility diseases • Principles of clinical investigation in assisted human reproduction

• Thesis: Comparative analysis of pericycle cells gene expression and differentiated protein accumulation in the primary root of the lrt1 maize mutant. – (original version in German)

• Specialised in plant and animal physiology and pharmacology • Final Project: ‘Differentiation, characterization and morphological analysis of NG108-15 cells.’ – (original version in German)