i have a degree in Pharmaceutical Chemistry and over ten years of Pharmacovigilance experience in multinational Pharmaceutical companies for medicinals, Medical Devices, supplements, nutraceuticals and cosmetics. i have acquired a deep knowledge of the Pharmacovigilance legislation locally and internationally interacting with external (regulatory authorities, partners) and internal (internal departments: Clinical, Marketing, regulatory) stakeholders. i have acquired a good experience in Pharmacovigilance (pv) audit activities hold and received at the international level.
Local QPPV Italy/ Compliance Manager ItalyDecember 2012 --- April 2016
local Qualified Person Pharmacovigilance - italy :
- creation and implementation of first Pharmacovigilance department (sops, trainings, sdeas,
literature, psurs) of italian affiliate
-contact point of regualtory authorities for medicines (aifa), Medical Devices, cosmetics,
supplements and nutritionals (ministero della salute).
-collaboration with regulatory, medical affairs and Marketing for the overview of products safety
pv Compliance & standards manager:
-cooperation of global Pharmacovigilance activities
-preparation of audits and inspections at global level
-management of capa (audit/inspection/Compliance) at global level
-overview of vendor activity to maintain the company Compliance
Safety Surveillance Specialist ItalyJuly 2002 --- December 2012
-evaluation of safety reports information (ae, sae) based on seriousness, causality and labeling according to national and international regulation and guidelines -reconciliation of Clinical trials -submission of safety reports to national and international regulatory authorities according to legislation (FDA, ich) -support the requests for preparation of safety reports (psur) -collaboration with different departments: Regulatory Affairs, Marketing, Clinical research.
Clinical Research Associate (CRA) ItalyNovember 2000 --- June 2002
-selection of sites and provition of necessary Training on science)" rel="nofollow">Protocol and ich gcp to investigators
-preparation Ethics and regulatory submissions before, during and after the study
-site administration and monitoring according to company sops, gcp and local legislation
-coordination of investigators activities to ensure science)" rel="nofollow">Protocol and study objectives Compliance
Master in Pharmacovigilance from University of milan in 2004
Bachelor in Pharmaceutical Sciences from university of Rome in 1996