Helene Bossu

- Global overview and owner of the procedures for complaints - Perform complaints trend analysis, track CAPAs and prepare periodical reports for Senior Management - Responsible for the performance of adverse events/technical complaints reconciliation - Coordinate the global Recall Assessment meetings - Lead the team of the sites Subject Matter Experts - Ensure training to employees and stakeholders is performed. - Continue to develop the complaint management system

- Intake, processing and tracking of technical complaints - Request of investigation to the manufacturing site and in charge of the final assessment of the manufacturing site’s investigations - Follow up of CAPAs with manufacturing sites - Contribution to Global Quarterly PTCs trends - Collaboration with Quality Manager for the preparation of audits

- Responsible for the Drug Safety Management of 4 clinical trials - Notification of serious adverse events to Ethics Committee and Health Authorities - Reconciliation with Data Management and contribution to Safety Update Reports - SPOC for Audits and Inspections within the Department

- Ensure that the batch records were distributed for completion - Translation of procedures from German into French - Co-pilot in the 5 S Project - Ensure that the GCPs were followed in clinical trials - Record of Adverse Events and notification of serious adverse events to Health Authorities - Data collection for Periodic Safety Update Reports - Responsible person for training staff in Eudravigilance system

- Responsible to ensure that GCPs are followed in a Gilead clinical trial. - Ensure timely screening of patients, ordering and shipment of clinical products, monitoring of the site through monthly call, ordering of patients diaries/booklets and shipment of the same to the clinical trials sites - In charge of submitting clinical trial forms to FDA

- Responsible for the organization of the accommodation for the personnel (hotel, apartments, request of stay permit) and distribution of weekly expenses - Preparation of monthly activities reports - Translation from French into English/Italian during the technical meetings - Responsible for the planning of the personnel in charge of tourists visits - Daily reports of incidents on the tram line for the President of Strasbourg City

- Treatment and translation of invoices from worldwide workshops - SPOC for the IVECO Head Quarters in Italy and Germany - Responsible for the minutes of team meetings

- Responsible for all administration requests from the customers - Cold calls of companies in Italy on behalf of the Sales and Marketing Director Participation to the main Italian fair for Tourism in Milan

- Treatment of invoices reminders, follow up of daily organization of to do list for the team - Contribution to the organization of the annual meeting of the Presidents from Swiss companies in Italy - Replacement of all team members during their annual leave and reception

- Translation of technical booklets and instructions - Mailing with the manufacturing sites - Secretarial tasks for the owner of the company - Punctual assistance of the sales department