Safety Science Specialist
About The Position
ultrafocused – 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.
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, workflows), and project management tools (MS Project, Smartsheet or similar).
- Strong organizational, communication, and multitasking skills with proven ability to work independently
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.
Benefits
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
