Eleonora Lucarelli Email & Phone Number

Roma, Lazio, Italia

Roma, Lazio, Italia

• Configuration of the company Quality System for Pharmacovigilance, by mapping the processes, writing and updating the procedures, operating instructions and internal rules of the organization;• Definition of policies and objectives of QA in Pharmacovigilance;• Drafting and revision of Pharmacovigilance Agreements and Safety Data Exchange Agreements;• Management Change Control, deviations and CAPA;• Definition and monitoring of Key Performance Indicators (KPIs);• Management of third parties' qualification;• Performing of Pharmacovigilance Quality System periodic review and continuous improvement of the System.

Roma, Lazio, Italia

• Planning, conducting and production of audit reports for supplier qualification audit and process audit;• CAPA plan evaluation and CAPA implementation monitoring.

Roma, Lazio, Italia

• Implementation and maintenance of the quality management system;• Design and definition of quality and compliance plans for management of operational activities related to Scientific Service department;• Drafting and revision of Standard Operating Procedures (SOPs) and Operating Instructions (WIs);• Drafting and revision of Quality Agreements, Scientific and Medical agreements;• Planning and participation in internal and second/third party audits;• Management Change Control, deviations and CAPA;• Definition and monitoring of Key Performance Indicators (KPIs);• Management of suppliers' qualification;• Planning and management of training according to company and profile's need, drafting and maintenance of reports;• Quality assurance for service provided to clients.

Roma, Lazio, Italia

• Management and coordination of projects in Regulatory Affairs Field• Management of lyfecicle and Marketing Authorization variations including submission to the European competent authorities (NAP, DCP and MRP procedures) and preparation of administrative documentation;• Management of Product Information (SmPC, PIL, label) and artwork revision and approval;• Regulatory monitoring of the Italian and European Official Journal and Health Authorities institutional websites (AIFA, Ministry of Health, EMA);• Management of Marketing Authorization transfers, request of product certificates for exportation (CPP, CLV) and manufacturing authorizations;• Management of optical Bollino and local traceability system;• Management of module 3 - Quality of the Common Technical Documentation and conversion from the old NtA format to the new CTD format for the management of dossiers in electronic format (eCTD), in accordance with current ICH guidelines;• Management of narcotics and related regulatory authorizations.

Roma, Lazio, Italia

• Quality control of the documentation before publishing in eCTD format;• Publishing activities;• Evaluation of the correctness/completeness in the formatting and navigation of the output sequence• Validation of published sequences including submission to Health Authorities;• Retention of generated eCTD sequences and related validation reports.

Roma, Lazio, Italia

• Management of lyfecicle and Marketing Authorization variations including submission to the European competent authorities (NAP, DCP and MRP procedures) and preparation of administrative documentation;• Management of Product Information (SmPC, PIL, label) and artwork revision and approval;• Regulatory monitoring of the Italian and European Official Journal and Health Authorities institutional websites (AIFA, Ministry of Health, EMA);• Management of Marketing Authorization transfers, request of product certificates for exportation (CPP, CLV) and manufacturing authorizations;• Management of optical Bollino and local traceability system;• Management of module 3 - Quality of the Common Technical Documentation and conversion from the old NtA format to the new CTD format for the management of dossiers in electronic format (eCTD), in accordance with current ICH guidelines;• Management of narcotics and related regulatory authorizations.

Roma, Lazio, Italia

• Monitoring and downloading of Adverse Drug Reactions (ADRs) from Eudravigilance;• Triage, validation and insertion of ADRs in the company Safety Data Base, both spontaneous and coming from literature screening;• Monitoring of local and international scientific literature;• Bibliographic research;• Drafting of safety aggregate reports.

Roma, Lazio, Italia

• Monitoring and downloading of Adverse Drug Reactions (ADRs) from Eudravigilance;• Triage, validation and insertion of ADRs in the company Safety Data Base, both spontaneous and coming from literature screening;• Monitoring of local and international scientific literature;• Bibliographic research;• Drafting of safety aggregate reports.

Roma, Lazio, Italia

Thesis project carried out at the Department of Chemistry and Drug Technologies of the University of Rome "La Sapienza". Preparation and discussion of an experimental thesis entitled “Characterization of metabolites in the Torpedino® tomato variety by mass spectrometric methods”.To obtain the metabolomic characterization of the discussed samples, high resolution analyzes were performed with a cyclotron ion resonance analyzer in Fourier transform (FT-ICR) and CID collision induced dissociation studies with a Paul Bruker Esquire 3000+ ion trap (both spectrometers coupled to ESI ion source). In addition, skills were acquired on the use of a Qtrap linear ion trap (ESI or APCI source) and data processing software / tools, such as Bruker DataAnalysis 3.4, Masstrix, Metlin, ChemCalc and Kegg Mapper.

Palestrina

Training internship with the acquisition of university CFUs carried out for a period of nine months at the pharmacy "Dr. Pellegrino", located in Palestrina (Rm), with drafting of the internship diary.

Laurea Magistrale Lm, Chimica E Tecnologia Farmaceutiche, 105/110

Diploma Di Istruzione Secondaria Superiore, 81/100