Safety Associate

**Location**: Italy **Schedule**: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Safety Associate. Where your responsibilities will include fulfilling all pharmacovigilance and medical device safety related activities, both during clinical trials, clinical investigations and studies or surveys during post marketing phrase. Join our team and help us deliver clinical trials that will improve patients' lives. **Main Job Tasks and Responsibilities**: - Collects, records and checks for mínimal requirements Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trials - Manage the generation of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow-up for ensuring efficient control and information flow - Perform the AE/SAE reporting to the Sponsor, guaranteeing smooth and efficient information flow - Prepare the case narratives, CIOMS I Forms, SAE Forms and all other applicable forms in order to perform safety reporting - Manage the Safety Database - Act as first point of contact for the Sponsor for safety matters - Perform the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR), arisen during clinical trials, to the Competent Authorities (CAs), Ethics Committees (ECs) and other recipients ensuring compliance with applicable regulations and appropriate handling - Manage the unblinding information - Perform the reporting through EudraVigilance via EVWEB, if qualified - Perform the periodic reporting to CAs, ECs and other recipients of safety documentation, ensuring compliance with applicable regulations and appropriate handling - Perform the safety reporting of reportable safety issues (SAE) arisen during clinical studies with medical devices to CAs, ECs and other recipients, ensuring compliance with applicable regulations and appropriate handling - Ensure tracking and documentation of the AE/SAE related correspondence creating set of information for future - Collect, record and manage the safety issues arising during the post marketing phase - Perform the reporting to the CAs, applicable ECs and other recipients during the post marketing phase - Keep abreast of all scientific, regulatory and operative aspects relevant to the clinical projects assigned - Prepare and review Safety Plans and AE/SAE Reconciliation Plans - Write the SOPs and Working Instructions in order to implement safety policy **Education and Experience**: - University Degree in scientific, medical or paramedical disciplines - Proven Safety experience - Excellent understanding of safety regulations in the EU Member States (e.g. ICH, CT3, MDD, AIMDD, MEDDEVs) and implementation in national laws - Ability to research safety requirements in International and National Regulation - Fluency in English and local language/s - Proficiency in Microsoft Office (e.g., Word, Excel, Outlook) **Our Benefits**: - Excellent work-life balance - Full performance and development process with end of year reviews - Team events and end of year party - Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally - Employee satisfaction survey - your feedback is important for continuous improvement **The Application Process** **Who will you be working for?** **_About CROMSOURCE _** CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do. **_Our Company Ethos _** Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates. CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all f