
Qualified Person for Pharmacovigilance and Clinical Expert (Advisor) at Tubilux Pharma
Rome Area, Italy

Qualified Person for Pharmacovigilance and Clinical Expert (Advisor) at Tubilux Pharma
Rome Area, Italy
My field of expertise is clinical research. While studying for taking my PhD (Ocular Patho-physiology), I spent ten years in the Ocular Physio-Pharmacology Department of “La Sapienza” University of Rome, where I had the opportunity to learn how developing ophthalmic drugs, taking part in preclinical studies on animal models and phase II-III clinical trials. Successively, since I started to work in pharmaceutical industry, I have planned, designed and coordinated several phase II and III clinical trials. Recently, I expanded my interests and experience in pharmacovigilance, acting as the Qualified Person for Pharmacovigilance for the company where I have been working. Therefore, as my professional background is a mixture of direct clinical practice as an ophthalmologist and experience in pharmaceutical industry, I have the skills to cope with any clinical affair in a peculiarly comprehensive way.
My job experience covers medical direction, pharmacovigilance, marketing support and sales force training
(Pharmaceuticals industry)
January 2006 — Present (4 years )
My responsibilities are:
1) acting as a single contact point for Competent Authorities on a 24-hour basis and input to drug safety and risk management systems for the company’s medicinal products and medical devices.
2) establishing and maintaining/managing the MAH’s pharmacovigilance system
3) assessment of risk/benefit ratio
4) evaluating alert signals and providing risk management plans
5) authorship of peridioc update safety reports
6) training periodically the company's personnel on pharmacovigilance
(Pharmaceuticals industry)
January 2000 — Present (10 years )
My responsibilities are:
1) managing medical affairs in outsourcing
2) providing a scientific support for the marketing division
3) training periodically the sale force
4) authorship of clinical protocols
5) supervision and cohordination of clinical trials
(Medical Practice industry)
January 1990 — Present (20 years )
private practice
PHD , Ocular Patho-physiology , 1993 — 1996
Specialisation , Ophthalmology , 1987 — 1991
MD , Medicine , 1981 — 1987
Maturità , Liceo Classico , 1976 — 1981
Skiing, movie making. Author of a novel published on 2007
Member of Italian Society of Ophthalmology (SOI)
Member of Association for Research in Vision and Ophthalmology (ARVO)
First prize for poster presentation at the International Meeting "Decision Making in therapy", held in Rome, Italy (Hypertensive effect of ibopamine and visual field defects in glaucomatous patients) - February 1996
Second prize for papers presented at the 5° Congress of European Glaucoma Society, Paris, France (Ibopamine in glaucoma diagnostics: a new pharmacological provocative test) - June 1996
Award for Clinical Research in Ophthalmology at the Annual Meeting of Italian Society of Ophthalmology (SOI) held in Rome, Italy (Hydrodynamic auto-regulation in normal tension glaucoma) - November 1999