Umoja Biopharma
Director, Pharmacovigilance
Remote; Seattle, Washington, United States · Director
Sponsorship not specifiedDetected 23 days ago
ComplianceRecruitingFDA RegulatoryPharmacovigilanceCommunicationCollaborationRegulatory Affairs
About the role
- Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)
- Participate in safety review meetings and cross-functional risk discussions
- Assist in development and implementation of Risk Management Plans (RMPs)
Responsibilities
- Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
- Coordinate with Clinical Development to drive internal cross-functional pharmacovigilance activities
- Support signal detection activities, including data review, trend analysis, and documentation
- 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
- This role will operate as an Individual Contributor and manage PV relationships with vendors and CROs to start.
- Aggregate Reporting & Regulatory Support
- Drive continuous improvement initiatives across PV operations
- 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.
Benefits
- Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time.
- 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
- Support safety sections of regulatory submissions and responses to health authority queries
- Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
- Support Medical Affairs in communicating safety information as needed
Apply directly at Umoja Biopharma →Create a free account for alerts like thisView Umoja Biopharma immigration profile
This listing is sourced directly from Umoja Biopharma's careers page and normalized into a canonical job model.