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Safety Science Specialist

Bedford, MA; or Brisbane, CA; or Novato, CA; or Somerville, MA; or Woburn, MA; or Remote- United States
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:

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

 
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
 
·         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
 
* Benefits vary by region and country

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.

See our Privacy Policy.

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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed totalentacquisition@ultragenyx.com.

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Voluntary Self-Identification Survey

We are dedicated to fostering an inclusive workplace environment that keeps our teams inspired, empowered, and free to share new ideas—and to better finding solutions that advance the treatment of those living with rare diseases.  We invite you to voluntarily provide demographic information in a confidential survey at the end of this application to assist us in complying with legal requirements and managing our organization. Providing this information is completely optional and it will not be accessible or used by those involved in your hiring or decision-making process. Your response – or decision not to respond, has no impact on your opportunity for employment. Responses to the voluntary self-identification requests will be confidential and securely maintained and only reported in the aggregate in support of the efforts outlined above.

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