Safety Science Specialist

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultra focused – Work together to fearlessly uncover new possibilities The Safety Science Specialist supports Global DSPV leadership Safety Science teams, working independently and collaboratively to execute operational projects aligned with business priorities. The role requires technical expertise and strong project management to enable smooth execution of projects, and organizational skills and hands-on experience with technical applications for collaboration and document management. This role will partner with leadership and Safety Science teams to create solutions and drive projects across the department. Work Model: Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Support pre- and post-marketing safety surveillance activities for all Ultragenyx products (investigational and marketed), in compliance with ICH guidelines, FDA/EMA and other applicable global health authority regulations, Good Pharmacovigilance Practices (GVP), and Ultragenyx policies and procedures. Support leadership and Safety Science meetings: agenda and meeting management, prepare materials, schedule meetings, prepare and finalize minutes capturing action items. Develop and maintain tracking systems (e.g., Smartsheet, Excel) and dashboards/metrics. Maintain project documentation, planning documents, dashboards, and status reports using SharePoint and other tools. Build and manage SharePoint sites including functional landing page, maintain functional or project documentation, create libraries, lists, workflows, and ensure proper permissions. Support document management including but not limited to using tools like Veeva (RIM, Quality, Document Control, Ultra Trial), Icertis, etc. Develop or contribute to development of Ultragenyx or department processes including policies, Standard Operating Procedures and other relevant safety documentation. Lead or support special projects as needed. Support inspections and audits: prepare slides, schedule meetings, prepare minutes, etc. Provide additional support as needed. Requirements: Bachelor's or master's degree in pharmacy, nursing, life science, or a related field, 2+ years experience in pharmacovigilance with basic knowledge of pharmaceutical clinical research and development Project Management or coordination experience Strong knowledge and demonstrated hands-on experience of Microsoft Office (Powerpoint, Excel, Word), SharePoint Online (site creation, document libraries, permissions, workf ... (truncated, view full listing at source)