Pharmacovigilance & Drug Safety

Biography

Giovan Giuseppe Mattera graduated as MD at the School of Medicine of the Pisa University in 1988. In 1992 achieved the PhD in Clinical Pharmacology. From 1989 to May, 1993 he worked as Scientist in Hemodynamics Lab - Department of Pharmacology- Guidotti SpA. In this role he was involved in project on the research of new inhibitors of Angiotensin and Endotelin Converting Enymes. In June 1993, he joins Sigma tau SpA where he serves as Head of New Experimental Model Lab (from 1993- to 1998) and Head of Cardiovascular Pharmacology Lab. - General Pharmacology Dept – R&D Area (from 1998 to 2002). Head of Cardiovascular Pharmacology and Safety Lab. – C&PNS and General Pharmacology Area (from 2002 to 2011) and Head of Pre-clinical Safety Lab. – General Pharmacology Area – Corporate R&D (from 2011 to 2013). In this period his principal research’s interests were: Pharmacology of Carnitin System; Physiopathology of Endothelium; Cardiovascular Diabetic Complications; Cardiac Insufficiency and research of new inotropic agents; Set up of the laboratories for C.V. Safety study in large animal and telemetric methods. Several studies of the effects on QT/QTc duration, of different class of New Chemical Entity under development. From May 2013 to now, he moved to Clinical Research Dep. of Sigma tau Corporate R&D as Head of Human Safety Unit. Moreover, from 2016, he serves also as Medical Qualified Person of Pharmacovigilance for Alfasigma SpA, the new group born from ST and Alfa Wasserman joining. In those positions, he prepare the clinical trials Safety Monitoring Plans, assures the safety monitoring and evaluation of IMP in clinical studies; supporting Clinical Research to define risk / benefit profile of IMPs. He exerts other Pharmacovigilance activities as Signal Detection and periodic safety reporting.

Research Interest

Pharmacovigilance,Clinical Trials and Safety Reporting