Drug Safety Officer Junior
Since May 2015
Support in managing Pharmacovigilance activities through constant monitoring of the safety of products, in compliance with national and international Pharmacovigilance rules for the entire company product portfolio (Corporate and non- Corporate products) with reference to the Italian territory; collecting and processing spontaneous reports from different sources (patients, healthcare professionals, Regulatory Authorities) in order to draw up proper documentation (CIOMS and xml); submitting reports of adverse drug reactions to Competent Authorities; assuring compliance with activities and timelines described in the safety data Exchange Agreement with Company partners; performing reconciliation activities; monitoring benefit/risk ratio with reference to Chiesi products (e.g. signal detection analysis); applying search strategies defined by SOP for monitoring scientific and medical literature; training of new employees.
Junior Drug Safety Officer
October 2013 --- May 2015
Collecting and processing Individual Case Safety Report (ICSRs) coming from EU and Extra-EU sources; data entry and quality control of ICSRs in the safety database; management of follow-up requests; preparation, MedRA coding and reporting of ICSRs including expedited and electronic reporting of them; submission to the Health Authorities and/or partners of case reports; review of scientific literature and sponsored websites.
Pharmacovigilance trainee programme
February 2013 --- August 2013
Monitoring the Italian Pharmacovigilance Network, analysing, evaluating ICSRs and managing missing information (follow up); Registering the ICSRs by using Oracle AERS as database and Medra as dictionary to codify inidcations, diagnoses, adverse reactions.
September 2012 --- December 2012
A business school that trained me in scientific disciplines and helped me to learn more about professions in pharmaceutical and biomedical companies.
January 2012 --- January 2012
Master's degree, Medicinal and Pharmaceutical Chemistry
January 2003 --- January 2011
September 2009 --- July 2010
Internship for Experimental Thesis at Laboratory of Organic Synthesis, headed by Prof. A.Bisi, Department of Pharmaceutical Sciences, Faculty of Pharmacy, University of Bologna, Italy. I improved my chemical skills and I discovered new chemical instruments that I wasn’t able to use during my courses. My job was to synthesize new chemical compounds following a research project. I used Nuclear Magnetic Resonance, Carousel Reaction Station, Flash Chromatography and other process to purify chemical compounds (crystallization, extraction, filtration). I had to learn very quickly to work in an effective and efficient way and to develop new responsibilities that are essential in a chemical laboratory.
September 2008 --- March 2009
Obligatory Internship at Pharmacy San Benedetto, Via Indipendenza, 54. Bologna, Italy. A very interesting experience where I learnt to provide excellent customer service to all patients, providing professional services or preparation of various products, i.e. creams and solutions. Moreover I dispensed medication as advised in prescriptions. My responsibilities included taking inventory, filling shelves, date checking. Here, I was able to put into practice what I had learnt at University, and also develop my knowledge on the treatment of various minor ailments.
in from Istud in 2012
Upper- Intermediate Certificate in English; IELTS Certificate in from British Study Centres, London in 2012
Intermediate Certificate in English in from British Study Centres, Brighton in 2011
License to work as a Pharmacist in from Università degli Studi di Ferrara in 2011