Silvia Gallipoli
Clinical Project Manager at Zeta Research- Claim this Profile
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Italiano Native or bilingual proficiency
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Spagnolo Professional working proficiency
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Inglese Professional working proficiency
Topline Score
Bio
Credentials
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ICH-GOOD CLINICAL PRACTICE TRAINING COURSE
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)May, 2021- Oct, 2024 -
QMS Internal Auditor
Lloyd's Register
Experience
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Zeta Research
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Italy
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Research Services
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1 - 100 Employee
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Clinical Project Manager
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Jan 2019 - Present
• Development and management of clinical trials, according to existing legislation, Good Clinical Practice, Investigational Plans e Standard Operative Procedure.• Business development• Feasibility study• Study design• Site Management• Protocol drafting• Study management and coordinating• Drafting of documents and processes required for submission to Regulatory Authorities and Ethical Committee• Drafting of monitoring report• Identification of any problem during the clinical study (deviations from the protocol, failure to comply with the timing, etc.) and definition of possible solutions• Clinical Data Management (Case Report Form design, eCRF implement, eCRF validation, eCRF testing)• OpenClinical training to the PI Data Entry• Medical writing• Organize meeting with the project team• Management of relationships with client companies
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Quality Assurance
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May 2020 - Present
• Drafting of Standard Operating Procedures• Maintenance and implementation of the quality management system, in accordance with the Ministerial Decree of 31 March 2008• Management of audits and inspections with Regulatory Authorities, Sponsors and Certifiers• Internal Audit (ISO 9001:2015, GCP, 21 CFR Part 11)• Management of Key Performance Indicator• Management of Corrective and Preventive Actions
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Clinpharma
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Italy
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Business Consulting and Services
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1 - 100 Employee
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Drug Safety Officer
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Mar 2017 - Dec 2018
• Local contact point for the customer companies• Possible role as QPPV / Deputy QPPV• Management of Adverse Event Report received at the customer companies• Access to National Pharmacovigilance Network (RNF)• Daily control of EudraVigilance, of other database and of the dedicated email, to check the possible inclusion of new adverse reactions / events regarding medicinal products and active substances• Screening of national and international scientific literature• Drafting and updating of the company electronic register relating to adverse reactions from all possible sources• Data Entry• Management of Adverse Drug Reaction, in collaboration with the Medical Expert• Drafting of periodic safety reports (PSUR/DSUR)• Preparation and updating of company schedules for the drafting of the PSUR/DSUR• Drafting of Module 1.8.2 (Risk Management Plan)• Provision of pharmacovigilance training for the internal and external staff of the client company• Internal and / or External Pharmacovigilance Audits in collaboration with the Pharmacovigilance office• Archiving in one place all the safety documentation• Management of collection, treatment, follow-up, analysis and regulatory reporting of adverse events (EA), serious adverse events (SAE), and Suspected Unexpected. Serious Adverse Reaction (SUSAR) for the products of the customer companies for which it provides a pharmacovigilance service• Insertion of ICSRs in Eudravigilance• Management of relationships with customer companies• Reconciliations with customer companies
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STAGE IN FARMACOVIGILANZA
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Sep 2016 - Mar 2017
Analysis of the suspected adverse drug reactions recorded in the National Pharmacovigilance Network (RNF)• Causality assessment• Reporting of the pharmacokinetic, pharmacodynamic and, if present, characteristics of the interaction profile between the drugs reported in the reports, with processing of the return information for the physiscian• Screening of national and international scientific literature• Support to pharmacovigilance managers of health facilities for the collection, within the specific activities of active pharmacovigilance, of spontaneous reports of adverse events and the processing of suspected adverse reaction form in the electronic reporting platform (Vigifarmaco)• Training and dissemination activities on pharmacovigilance
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TIROCINIO PRATICO PROFESSIONALE PRE – LAUREA E POST – LAUREA
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Sep 2014 - Sep 2016
• Execution of instrumental checks to ensure compliance with legal obligations regarding the prescriptions presented at the time of purchase, storage and dispensing of drugs• Advice, dispensation and surveillance in the sale of prescription drugs• Advice and dispensation of parapharmaceuticals• Health advice also through the provision of equipment and health aids • Execution of instrumental checks to ensure compliance with legal obligations regarding the prescriptions presented at the time of purchase, storage and dispensing of drugs• Advice, dispensation and surveillance in the sale of prescription drugs• Advice and dispensation of parapharmaceuticals• Health advice also through the provision of equipment and health aids
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Università degli Studi di Napoli Federico II
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Italy
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Higher Education
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1 - 100 Employee
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TESI SPERIMENTALE
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Sep 2014 - Jul 2015
Experimental thesis in Pharmaceutical Chemistry and Toxicology titled "Synthesis of fluorescent peptides as substrates of callicrein 7" (supervisor Prof. V. Santagada) Experimental thesis in Pharmaceutical Chemistry and Toxicology titled "Synthesis of fluorescent peptides as substrates of callicrein 7" (supervisor Prof. V. Santagada)
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Universidad Alfonso X el Sabio
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Spain
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Higher Education
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700 & Above Employee
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ERASMUS
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Sep 2013 - Feb 2014
Toxicología, Tecnología Farmacéutica, Nutrición y Bromatología, Español. Toxicología, Tecnología Farmacéutica, Nutrición y Bromatología, Español.
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Education
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2016 - 2017
Università degli Studi di Milano
Master Universitario annuale di II livello in Farmacovigilanza (70 CFU), Farmacologia -
2010 - 2015
Università degli Studi di Napoli 'Federico II'
Laurea Magistrale LM, Farmacia -
2005 - 2010
Liceo Classico G.B.Vico
Maturità Classica, Maturità Classica
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