Paolo has over 18 years of experience in the pharmaceutical and CRO industries as a statistician, manager and owner/CEO of a Life Sciences holding company. He created seQure in 2014 (formally PM Clinical) as part of PM Holding, a Life Sciences holding group which includes CROS NT (CRO) and Arithmos (Life Sciences technology).
Antonella has over 20 years experience in Pharmaceutical R&D with leadership and management experience of global, multi-disciplinary teams, across all phases of drug development. Prior to starting with seQure in 2017, she held positions at Aptuit as Head of Quality and Compliance ensuring compliant GLP and GMP Quality Systems for Verona and Oxford, as well as GSK and GW with responsibility for Business and Projects Operations in Preclinical Development.
STEFANIA DE SANTIS
Director of Pharmacovigilance
Stefania De Santis, is a qualified EU QPPV and is seQure’s Director of Pharmacovigilance; as such she is responsible for strategic planning and workflow development as well as guaranteeing the quality of our pharmacovigilance services. Stefania has almost 30 years of experience in the pharmaceutical sector where she has been involved in various departments throughout her career. Before joining seQure she was dedicated to the field of pharmacovigilance as Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company since 1992. Stefania has extensive experience in all pharmacovigilance operations, in both pre-registration and post-marketing settings, case processing, PSUR and DSUR preparation, ICSR/SUSAR electronic transmission to the EMA, safety database validation, safety variations, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities. She is certified by the EMA for the use of Eudravigilance and EXVMPD (Medicinal Product Dictionary).
seQure provides expert pharmacovigilance, quality management and assurance, regulatory and computer system validation solutions to drug and device companies to help them meet regulatory requirements. These services are provided as consultancy, as projects or on a functional service provision basis where a team is selected to provide a customer with ongoing services. We strive to meet specific needs of clients in the following sectors: pharmaceutical, biotechnology, medical device, Academic institutions and associations as well as CROs (Contract Research Organization) and Service Providers.