We are a team of European industry experts that provide pharmacovigilance, quality management and assurance, regulatory and computer system validation solutions. Our goal is to support our clients in safeguarding patients health and improving their lives in a smart, innovative and cost-efficient manner.
Our mission is to support our clients in safeguarding patients’ health and improving their lives in a smart, innovative and cost-efficient manner.
Our Management Team
CEO of PM Holding and seQure
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 also 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).
Head of Business Development
Umran has over 18 years of experience in Information Technologies and Business Transformation, helping companies to built digital strategies with innovative and creative solutions that unleash the power of technology to achieve high-value business performance. Versatile, energetic and inspiring leader, she joined seQure to empower the shared success for our customers and business partners. Umran holds a degree in Industrial Engineering from Istanbul Technical University (Turkey) and a degree in Master of Laws (LL.M.) from Università degli Studi di Milano (Italy).