Experience

Pharma D&S

• Italy
• Business Consulting and Services
• 100 - 200 Employee

• Senior Drug Safety Officer and Team Leader

  • Oct 2022 - Present



ASGENIA

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Dec 2021 - Sep 2022

  Pharmacovigilance contact point for National Competent Authorities in Member States and EMA.• Overview of safety profiles of the medicinal products and any related emerging safety concerns.• Collection, management and communication of safety data.• Notification of changes in risk/benefit balance of a medicinal product to the competent authorities and/or the Agency.• Insert and update of relevant data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).• Preparation and update of the Pharmacovigilance System Master File (PSMF).• Ensure the correct functioning of the pharmacovigilance system.• Evaluation and approval of Safety Data Exchange Agreements (SDEA).• Reporting to EudraVigilance or contractual partners of ICSRs directly received by reporter. Show less

• • Mar 2021 - Sep 2022

  • EXPEDITE REPORTING: Management of reports. Submission in EudraVigilance of spontaneous and non-spontaneous, serious and non-serious ICSRs related to active ingredients or SM.• XEVMPD: insertion and updating of products in the eXtended EudraVigilance Medicinal Product Dictionary. Management and updating of the product list of client companies with related SmPCs.• PSMF: preparation and updating of the PharmacoVigilance System Master File• SDEA: preparation and updating of the Safety Data Exchange Agreement. Periodic reconciliations of ICSRs, product complaints, medical enquiries with Partners.• CASE MANAGEMENT: Daily access to EVWEB. Collection, screening, managing and archiving of ADRs / AEs (Adverse Drug Reaction / Adverse Event) relating to active ingredients and / or medicinal specialties, within the company database (SafetyDrugs).Elaboration and Transmission of Individual Case Safety Reports (ICSR) in XML and CIOMS format. Periodic reconciliations of the ICSRs transmitted to the client companies.National and international screening of scientific literature through the use of the "Pharmacovigilance Insight" databaseNational and international screening of scientific literature monitored by EMA (MLM)Non-indexed National Literature Screening.Active FU managementCopy cases to the company database Show less



Egualia – Industrie Farmaci Accessibili

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Drug Safety Officer - Asgenia S.r.l

  • Feb 2018 - Sep 2022

  • Collection, management and communication of safety data. • Insert and update of relevant data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). • Preparation and update of the Pharmacovigilance System Master File (PSMF). • Ensure the correct functioning of the pharmacovigilance system. • Evaluation and approval of Safety Data Exchange Agreements (SDEA). • Reporting to EudraVigilance or contractual partners of ICSRs directly received by reporter (expedited reporting) •Daily access to the EudraVigilance (EVWeb) •Collection, collation, processing and archiving of Individual Case Safety Reports (ICSRs) within the company DataBase SafetyDrugs® •National and international screening of scientific literature through the use of Adis Insight® database, the EudraVigilance web platform (MLM Service) together with screening of national non-indexed paper and digital literature •Management of follow-up (FU) queries for ICSRs and forwarding of relevant FU requests to the Italian competent local health units/reporters and collected information to Marketing Authorization Holder client pharmaceutical Companies. •Conduct of periodic reconciliation of exchanged ICSRs with MAH client companies/business partners Show less



Alfa Intes Industria Terapeutica Splendore

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Microbiologo controllo qualità

  • Jul 2017 - Jan 2018

  ▪ Controlli GMP su prodotti sterili e non sterili. ▪ Controllo qualità mediante test microbiologici su materie prime, semilavorati e prodotti finiti ▪ Controllo sterilità (test eseguiti in cleanroom in accordo alle line guida EU-GMP, test per filtrazione su membrana, test per inoculo diretto) ▪ Monitoraggio ambientale (conteggio particellare, conteggio microbiologico in aria, conteggio microbiologico sulle superfici e sul personale, identificazione dei microorganismi mediante sequenziamento del DNA Show less



Agenzia Regionale per la Protezione Ambientale Campania (ARPAC)

• Napoli, Italia

• Biologo Controllo Qualità - stagista

  • Feb 2016 - Sep 2016

  Analisi chimico-fisiche e microbiologiche delle acque destinate al consumo umano, nel rispetto della norma UNI CEI EN ISO/IEC 17025, e utilizzando le relative tecniche, parametri quali torbidità, colore, pH, conducibilità, concentrazione ioni idrogeno, anioni (fluoruro, cloruro, nitrato, solfato), Coliformi totali, Escherichia coli, Enterococchi, Pseudomonas aeruginosa, Staphilococcus aureus, Funghi Analisi chimico-fisiche e microbiologiche delle acque destinate al consumo umano, nel rispetto della norma UNI CEI EN ISO/IEC 17025, e utilizzando le relative tecniche, parametri quali torbidità, colore, pH, conducibilità, concentrazione ioni idrogeno, anioni (fluoruro, cloruro, nitrato, solfato), Coliformi totali, Escherichia coli, Enterococchi, Pseudomonas aeruginosa, Staphilococcus aureus, Funghi



AZIENDA OSPEDALIERA UNIVERSITARIA FEDERICO II

• Napoli, Italia

• Studente tirocinante

  • Oct 2014 - Dec 2015

   Diagnosi prenatale per Talassemia  Screening genetico  Analisi biochimico-cliniche  Ricerca  Diagnosi prenatale per Talassemia  Screening genetico  Analisi biochimico-cliniche  Ricerca