BrightOwl Loader Loading

Summary

MSc Degree in Pharmacy. One year experience in a private pharmacy. Actually, student of Second Level Master in Research and Preclinical and Clinical Drug Development of Milan–Bicocca University, Department of Medicine. Especially interested in drug safety and so working as Junior Pharmacovigilance Officer Trainee.

Experiences

Current Experience

  • Junior Pharmacovigilance Officer
    Since November 2014
    - Review and periodic updates of SOPs in compliance with current legislation, European and US guidelines; - Periodic Pharmacovigilance checks using RNF, EudraVigilance and Pubmed; - Data entry of cases (initial and follow-up) using appropriate Pharmacovigilance data base - PcV Manager; - Evaluation of adverse drug reaction reports based on texts approved by Regulatory Authorities; - Preparation of "Expedited Reports" and Periodic Reports of adverse drug reaction for final dosage forms.

Past Experience

  • Pharmacovigilance Officer - Trainee
    June 2014 --- November 2014
    - Review and periodic updates of local SOPs and OMs in compliance with current legislation, European guidelines and Global procedures/standards; - Maintenance of an updated collection of all applicable regulatory obligations and guidelines pertinent to drug safety; - Archiving of all original data referring to cases; - Data entry of local cases (initial and follow-up) using appropriate Pharmacovigilance data base - ARGUS; - Notification to local study manager of all SAEs cases observed during a clinical trial and forwarded to local Competent Authorities; - Review of all technical complaints related to safety; - Review of the Informed Consent Form; - Review of SPC and PIL safety sections.

  • Pharmacist trainee
    February 2013 --- March 2014
    - Dispensing prescriptions; - Checking prescriptions for errors and making sure they are appropriate for patients. - Informing patients on how to use drugs, their correct storage and their possible side effects; - Communicating with patients, establishing good relationships.

Knowledge

LinkedIn Assessment :
FDA inspection on Pharmacovigilance processes passed whitout major findingsIndustria FarmacéuticaFarmacovigilanzaSOPRicerca clinicaFarmaceuticaFarmacologiaScienze naturaliDrug DevelopmentSperimentazioni clinicheRegulatory affairs

Education

  • in Second Level Master in Research and pre-clinical and clinical development from Università degli Studi di Milano-Bicocca in 2015
  • Master of Science (MSc) in Pharmacy in from Seconda Università degli Studi di Napoli in 2012
  • High School Diploma in Scientific Studies (bilingual class: English and French) in from Liceo Scientifico A. Diaz in 2007

Area / Region

Monza, Province of Monza and Brianza, Italy

Others

Driving License
  • No