
Elena Borgo
Part Time Collaborator

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About me
Clinical trial start up specialist, Pharmacovigilance Officer
Education

Istituto di Istruzione Superiore Saluzzo-Plana
2003 - 2008High School Diploma Psychopedagogic high school 100/100
Università degli Studi del Piemonte Orientale 'Amedeo Avogadro'
2011 - 2013Laurea Magistrale Master's Degree in Biology (Physiopathological Profile) 110/110 with honours, awarded a distinction and right to be published.Experimental thesis: “Modulazione del calcio intracellulare da parte di epigallocatechina-3-gallato in cellule di carcinoma mammario MCF-7" ("Modulation of intracellular calcium by epigallocatechin gallate in MCF-7 breast cancer cells").

Università degli Studi del Piemonte Orientale 'Amedeo Avogadro'
2014 - 2014Qualification exam to exercise the profession of Biologist (Section A).
Università degli Studi del Piemonte Orientale 'Amedeo Avogadro'
2008 - 2011Laurea triennale Bachelor’s Degree in Biology (Biomedical Profile) 110/110Thesis: "Analisi computazionale degli effetti combinati in vitro di sostanze antitumorali” ("Computational analysis of in vitro combined effects of anticancer substances").
Experience

Università degli Studi del Piemonte Orientale
Jan 2010 - Aug 2010Part Time CollaboratorBacking of library activities, front-office activities for students, data-entry through office automation software, filing clerk.

Università degli Studi del Piemonte Orientale
Feb 2013 - Jul 2013Part-time collaboratorBacking of library activities, front-office activities for students, data-entry through office automation software, filing clerk.

Istituto Professionale dei servizi per l’enogastronomia e l’ospitalità alberghiera “Artusi”.
Feb 2014 - Sept 2016Teacher – High school- Organization of the educational activities on: Nutrition Science, Biology, Chemistry, Earth Sciences- Internal Commissioner of nutritional science during the final high school exams (2015/2016).

Università del Piemonte Orientale
Sept 2014 - Dec 2015Research FellowScholarship "Misure sui PCM" (“Measures on PCMs”) as part of the European project “PIE VERDE".Laboratory of Physics for the environment.Research Purpose: developing innovative ecological and eco-sustainable heat storage systems based on PCM (phase change material), made of capric and lauric acid, for the air-conditioning of the Iveco Daily Electric vehicle. The activity was carried out while teaching (see above).

Università del Piemonte Orientale
Jul 2016 - Oct 2016Research FellowLaboratory of Physics for the environment.Scholarship: “Valutazione dell’efficacia di trattamenti innovativi in agricoltura”. ("Assessing the effectiveness of innovative treatments in agriculture"). Measures to evaluate biological treatments for pest control in vineyards.

FIL - Fondazione Italiana Linfomi
Oct 2016 - nowClinical trial start up specialist -Pharmacovigilance OfficerOctober 2016 – December 2019: Alessandria, Spalto Marengo 44 c/o Uffici PACTO (AL)December 2019 – ongoing: Modena - Via Giovanni Dalton 48 (MO).- Study Start up: Drafting and review of scientific documentation of clinical trials. Production of the necessary documentation to obtain regulatory authorizations (ISS, AIFA, Garante Privacy, Italian ethics committees, clinical centres) for activating interventional and non-interventional clinical trials. Preparation of documentation relating to amendments (substantial, non-substantial, urgent), suspension or closure of the trial. Documents submission. Collection, recording and updating of clinical trials data on the European web portals (CTIS, AIFA OsSC, ClinicalTrials.gov). TMF update. Preparation of SOPs. Drafting and submission of Clinical Study Reports.Management of Investigator meetings.- Pharmacovigilance: Management of pharmacovigilance activities within the scope of clinical trials. Establishment and management of international Data Safety Monitoring Boards. Management of SAEs. Recording of SUSARs on EudraVigilance in compliance with current regulations (EMA Certified user).XEVMPD certified user by EMA. Reconciliation activitieswith clinical centers, with the aim of monitoring trial activities, in conjunction with pharmaceutical companies (e.g., sending query). Drafting and submission of DSURs. Support provided to the area manager in the management of the pharmacovigilance portal.Management site activation through R-SIV.- Internal quality auditor (since 2019). UNI EN ISO 19011:2018 certified, AICQ SICEV approved. Show less
Licenses & Certifications

English course - Upper intermediate level (Sep 18-May19)
British school
English course - Upper-Intermediate level (set ‘17 – giu ’18)
British school
ISO9001:2015 - Aggiornamento Auditor/Lead Auditor
Bureau Veritas GroupDec 2021
Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
European Medicines AgencyNov 2022
The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format - Certificazione ottenuta: EudraVigilance – HQ User (electronic reporting of ICSRs). Novembre 2017
European Medicines Agency
Basic Module for Auditors (UNI EN ISO 19011:2018 certified, AICQ SICEV approved)
KiwaDec 2019
Languages
- itItaliano
- inInglese
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