Description
Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
POSITION SUMMARY:
The Director of Pharmacovigilance (PV) will play a critical role in executing Umoja Biopharma’s global safety strategy across clinical-stage programs. This individual will be responsible for day-to-day pharmacovigilance operations, ensuring high-quality safety data management, regulatory compliance, and effective signal detection.
Working cross-functionally with Clinical Development, Regulatory, and external partners, the Director will help build and optimize scalable PV processes to support Umoja’s advancing pipeline, with an emphasis on operational excellence and inspection readiness.
This role will operate as an Individual Contributor and manage PV relationships with vendors and CROs to start. This person may be responsible for building the Pharmacovigilance team and organization in Umoja in the near future.
This position will ideally be based out of our Seattle, WA office and work onsite at least 2 days/week. This position may have the ability to be remote in the US based on candidate experience.
CORE ACCOUNTABILITIES:
Pharmacovigilance Operations
- Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
- Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
- Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
- Support maintenance of safety databases and related systems (e.g., Argus, ArisGlobal)
- Coordinate with Clinical Development to drive internal cross-functional pharmacovigilance activities
Aggregate Reporting & Regulatory Support
- Lead or contribute to preparation of DSURs, PSURs/PBRERs, and IND safety reports
- Support safety sections of regulatory submissions and responses to health authority queries
- Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)
Signal Detection & Risk Management
- Support signal detection activities, including data review, trend analysis, and documentation
- Participate in safety review meetings and cross-functional risk discussions
- Assist in development and implementation of Risk Management Plans (RMPs)
Cross-Functional Collaboration
- Partner with Clinical Development on protocol safety design, adverse event monitoring, and investigator communications
- Collaborate with Regulatory Affairs to ensure alignment on safety reporting strategy
- Support Medical Affairs in communicating safety information as needed
Inspection Readiness & Quality
- Ensure PV processes are audit- and inspection-ready
- Participate in internal audits, vendor audits, and regulatory inspections
- Drive continuous improvement initiatives across PV operations
The successful candidate will have:
Education & Experience
- Advanced degree (PharmD, PhD, MD, or MS) or health-related degree/certification (PA, RN, NP)) with at least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry is required
- Experience supporting clinical-stage programs and working with outsourced PV models
- Exposure to regulatory submissions and inspections preferred
Technical Expertise
- Strong working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
- Experience with safety databases and case processing workflows
- Familiarity with aggregate reporting and signal detection processes
- Experience in oncology, cell therapy, or gene therapy preferred
Leadership & Operating Style
- Strong execution focus with attention to detail and quality
- Ability to manage external partners and influence cross-functional teams
- Comfortable operating in a fast-paced, evolving biotech environment
- Proactive problem-solver with sound judgment
Physical Requirements:
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