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.
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.
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.
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