Daniela has a degree in Biological Sciences and began her professional career in 1990 in the Regulatory Affairs Department at SIAPA (a Pesticides Products Manufacturing Company) and then joined the Pharmacovigilance Department at Janssen.
In 1993 she was hired by Sigma-Tau i.f.r. S.p.A. as a Clinical Auditor. In 1999 she became Head of the Clinical Quality Assurance Department of Sigma Tau, and then in 2008 she assumed the position of Head of Corporate R&D QA.
In 2014 Daniela moved to PM Clinical, as Quality Assurance & Compliance Director.
Daniela has a very long and extensive experience in Quality System Management, GxP Quality Assurance and regulatory compliance, including Good Pharmacovigilance Practice. She has conducted and supervised hundreds of GxP audits, as well as audits to CROs, Labs and Suppliers. She is qualified as Responsible Person /Internal Auditor within the ISO 9001 Quality Management Systems.
She has experienced FDA, EMA, Local Authorities (AIFA, Austrian Health Authorities) and GxP Inspections and has attended meetings with European Inspectors in Rome and in London as well.
She is an active member of SSFA (“Società di Scienze Farmacologiche Applicate”), the Italian Group for Quality Assurance in Research and member of the British Association of Research Quality Assurance and AFI (“Associazione Farmaceutici Italiani”).
She has worked on several projects with the aim of promoting the Quality culture and Compliance in the Pharmaceutical and Academic environment as well.
She has attended several congresses as a speaker or chairman, as well as conferences and workshops both nationally and internationally. She has published several works including the SSFA “Pharmacovigilance Audit Manual”in 2010.
Stefania De Santis, is a qualified EU QPPV and is PM Clinical’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. However since 1992, she has been dedicated to the field of pharmacovigilance as Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company. 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).