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Summary

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.

Experiences

Past Experience

  • Local QPPV Italy/ Compliance Manager Italy

    December 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 Italy

    July 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) Italy

    November 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

Education

  • Master in Pharmacovigilance from University of milan in 2004
  • Bachelor in Pharmaceutical Sciences from university of Rome in 1996

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency

Area / Region

Italy

Others

Driving License
  • Yes

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