• Managing and processing serious and non-serious individual case safety reports via Argus® (Oracle) database obtained from spontaneous source, interventional clinical study (including Suspected Unexpected Serious Adverse Reactions - SUSARs), non interventional study, literature report and from license partner.• Manage case-related information including interpretation of medical condition, lab results and procedures, review, rank, verify, process and document: event terms coding using MedDRA medical dictionary; case classifications (validity, seriousness, expectedness/listedness/labelledness); product complaint and off label report; reportability with due date; accuracy and consistency;• Determine and perform appropriate case follow-up, generating and requesting follow-up letters.• Develop and maintain expertise and knowledge of all assigned antinfective products and vaccines within the therapeutic area;• Generate reports, ensuring adherence to regulatory compliance timelines (i.e FDA, EMA, MHLW), determining appropriate prioritization criteria, and noting reasons for any delays. • Liaise with license partners and other stakeholders regarding safety data collection and data reconciliation. • Prepare narrative and periodic comprehensive written reviews of all assigned adverse events• Participation in cross-functional training to ensure adherence to organizational policies and procedures.

• Entering information from adverse event in AERS® database according to standard operating procedure (SOPs);handling of adverse events of clinical study reports according to Good Clinical Practice (GCP), archiving of the documentation; requesting of follow-up activities to ensure accuracy of data and for reconciliation purposes; submission of cases to competent authorities • Evaluation of the effectiveness and safety of a drug according to RECIST criteria, Hematological criteria and CTCAE); • Quality review and checking cases for discrepancies for any errors related to labeling and narrative writing• Collaborated with internal departments and investigative clinical research sites to ensure compliance with safety processes• Revision, updating and writing of Clinical Study Reports (ICH-E3) for clinical trials of Phase I and II, Investigator's Brochure, Periodic Safety Update Report (PSUR) according to the guidelines; Assisted in the preparation of SOPs, preparing line listing reports, utilized regulatory and medical knowledge to assess claims.• Preparation and review of Ethics and Regulatory submission for start up and conduct of clinical trials according to GCP in Regulatory Affairs department

• Cellular biology on animal model and human tissue; • Derivation from wt and Rab3A ko mouse kidney of renal glomeruli, podocytes and glomerular endothelial cells;• Preparation of a co-colture between podocytes and glomerular endothelial cells to mimic the in vivo condition;• Immunofluorescence techniques on cells and tissues and immunological essays (in cell ELISA);• Molecular biology techniques (Western blot, PCR, RT PCR, isolation of miRNA); • Extraction of bacterical DNA and transfection techniques in vivo and in vitro.

• Cellular biology and molecular biology techniques (i.e. Western blot, derivation of dendritic cells from bone marrow and spleen, preparation of sample for FACS analysis);• Methods for measures of calcium levels;• Immunological essays (ELISA);• Use of animal models

• Preparation of urine samples for chemical – physical and macroscopic exam, of faeces for complete and parasitological exam;• Evaluation of microbiological exam on different samples