
Safety Science Specialist
Position Summary:
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.
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, workflows), and project management tools (MS Project, Smartsheet or similar).
- Strong organizational, communication, and multitasking skills with proven ability to work independently
#LI-CS1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$96,900 - $119,700 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Create a Job Alert
Interested in building your career at Ultragenyx Pharmaceutical? Get future opportunities sent straight to your email.
Apply for this job
*
indicates a required field