.Senior Project Lead, Patient Safety - Grade: P2-2 (Information for internal applicants) - Location: Greece, Italy, Portugal or Spain - 100% remoteAre you ready to take the reins of patient safety in diverse global projects? As Senior Project Lead in Patient Safety Services, you'll guide a spectrum of studies, from high-volume Phase I trials to intricate global late-phase Oncology Studies. Are you excited to lead, collaborate, and make an impact on drug safety across multiple functions and regions?Ready to amplify your leadership from regional to global impact? Begin as a regional leader and evolve into a global influencer as you gain experience.Can you envision yourself spearheading critical patient safety operations and collaborating with stakeholders on an international scale? Do you thrive in dynamic, client-focused environments? Join us in this home-based position that connects you with cross-functional project stakeholders and our global Patient Safety team. Are you ready to be the driving force behind compliant safety reporting, communication, and harmonization to exceed client expectations?Want to shape the future of patient safety with a leading CRO? Fortrea invites you to contribute your extensive drug safety expertise. You will have the chance to influence safety management plans, interact with clients, and actively participate in shaping safety protocols for a range of products.As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Duties and Responsibilities: Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.Ensure compliant safety reporting in accordance with international reporting regulations, SOPs and safety processing guidelines, for assigned projects.Support preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Development Safety Update Report (DSUR), Periodic Safety Reports (PSRs), line listings, and aggregate reports.Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This may include acting as safety lead for projects at a global or regional level, ensuring communication and process harmonization.Work with internal or external partners for reconciliation of safety databases, if appropriate.Draft/modify and deliver safety presentations as required, to external and internal stakeholders
