Local Specialist Safety Officer

4 settimane fa

Roma, Italia Excelya A tempo pieno

Local Specialist Safety Officer (Pharmacovigilance) Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development. Excelya's vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe. For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects. To learn more about us, visit Exceya is looking to collaborate with a Freelancer Local Specialist Safety Officer (Pharmacovigilance) , full-time (approximately 140 hours per month) , based in Italy. The position is full remote. Excellent knowledge of English and local language are required for this role. The role: The Local Specialist Safety Officer is Accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate. They are the primary contact for pharmacovigilance at the Affiliate and the nominated contact person for pharmacovigilance (“Local QPPV” equivalent) as notified to the local Health Authorities. They are also responsible for Medical Information at the affiliate Responsibilities: Supports the Country Safety Head in country related PV activities. Deputizes for the CSH in times of planned or unplanned absence of the CSH. Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. Supports the CSH in ensuring that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country. Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager. Supports the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements. Supports the maintenance of the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards. Monitors continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners. Handles appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs. Skills: At least 2 years of experience in pharmacovigilance/clinical development, pharmacovigilance systems and safety related product management. Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree will be a plus. Robust understanding of national PV regulations regarding safety requirements. Pragmatic, solution oriented mindset, problem-solving, prioritize, detail-oriented, and meet challenges. Good written and verbal communication skills in English and local language are required. FIELD SERVICE ENGINEER - CHIMICA ANALITICA - LAZIO #J-18808-Ljbffr

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