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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 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 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