Cecilia Maffei

Qualified Person for Pharmacovigilance @Recordati

Milan, IT

Specialty & Primary Care (SPC)-QPPV:• Overall responsibility for the global Pharmacovigilance system and Quality System of the SPC Business Unit.• Leadership and oversight of pharmacovigilance and risk–benefit management activities worldwide, across EU and non-EU territories.• Governance of global PV processes, compliance, vendor oversight and cross-functional interfaces.EEA / UK-QPPV:• Establishment and maintenance of the EEA and UK PV Systems, in compliance with applicable legislation and aligned with the global SPC PV framework.• Continuous oversight of the safety profiles of SPC medicinal products authorised in the EEA and UK.National Contact Person for Pharmacovigilance (Italy):• Primary local PV contact for Italian Competent Authorities, ensuring execution of all required local PV activities.Non-Pharmaceutical Products• Oversight of post-market surveillance and vigilance activities for medical devices, cosmetics and food supplements.

Università degli Studi di Milano

Speciality Level, Degree in applied biology to biomedical research

Universita' degli studi di pavia

Master's degree, Pharmaceutical technology and regulatory affairs