ppLOCAL QPPV - FREELANCE 0.2 FTE - HOME BASED (only in Italy) /p h3About this role /h3 pTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. /p pThe local QPPV acts as the local pharmacovigilance representative in Italy and serve as the primary liaison between the Italian affiliate, Agenzia Italiana del Farmaco (AIFA), and the EU QPPV, ensuring the implementation and compliance of local pharmacovigilance requirements. Ultimate responsibility for the pharmacovigilance system remains with the EU QPPV. /p h3Key Responsibilities /h3 pRegulatory Support and Authority Interactions /p ul liAct as the local point of contact for pharmacovigilance matters with AIFA. /li liFacilitate communication between the company, the EU QPPV, and Italian regulatory authorities. /li liSupport the preparation, coordination, and submission of responses to pharmacovigilance-related regulatory requests. /li /ul pSafety Information Management /p ul liSupport the collection, follow-up, and escalation of adverse events and other safety information originating in Italy. /li liEnsure that all local safety information is forwarded to the global pharmacovigilance system within the required timelines. /li liCollaborate in case follow-up activities and obtaining additional safety information when required. (en.direnzo.biz) /li /ul pPharmacovigilance System Compliance /p ul liSupport the implementation and maintenance of the Pharmacovigilance System and applicable local procedures. /li liEnsure that local pharmacovigilance activities are performed in accordance with Good Pharmacovigilance Practices (GVP), corporate procedures,



and national requirements. /li liMaintain awareness of Italian pharmacovigilance regulations and communicate relevant regulatory updates to the organization. /li /ul h3Qualifications /h3 ul liBachelor’s Degree, preferably in life science or nursing; or equivalent /li li5+ years of relevant experience /li liAble to work in a fast-paced environment with changing priorities /li liUnderstand the medical terminology and science associated with the assigned drugs and therapeutic areas /li liUnderstanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs /li liAbility to work independently as well as in a team matrix organization with little or no supervision /li liExcellent written and verbal communication skills /li liDemonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus /li /ul h3What We Offer /h3 pWe provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients. /p pOur core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference. /p h3A Bit More About Us /h3 pOur journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. /p /p #J-18808-Ljbffr

📌 Local QPPV - FREELANCE (Roma)
🏢 Tfs Healthscience
📍 Roma