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Director, Pharmacovigilance
Umoja BiopharmaDirector of Pharmacovigilance at Umoja Biopharma overseeing global safety strategy operations. Collaborating with Clinical Development and regulatory partners in biotech to ensure compliance and operational excellence.
Posted 6/30/2026full-timeSeattle • Washington • 🇺🇸 United StatesLead💰 $204,000 - $305,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance, ensuring compliance with global safety reporting requirements and managing relationships with vendors. Proficient in preparing regulatory submissions and maintaining safety databases.
Highest-signal resume keywords
Pharmacovigilance ExperienceGlobal Safety Reporting ComplianceRegulatory Submissions PreparationSafety Database ManagementAggregate Reporting Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case ProcessingMedical Review SupportSignal DetectionDSUR PreparationPSUR PreparationIND Safety ReportsSOP DevelopmentPharmacovigilance System Master File Management
Soft Skills
Relationship ManagementLeadership
Tools & Technologies
Safety DatabasesPharmacovigilance Systems
Certifications & Qualifications
PharmDPhDMDMSPARNNP
Industry Keywords
BiotechPharmaceuticalOncologyCell TherapyGene TherapyFDAEMAICH
About the role
Key responsibilities & impact- 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
- Lead 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)
Requirements
What you’ll need- Advanced degree (PharmD, PhD, MD, or MS) or health-related degree/certification (PA, RN, NP)
- At least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry
- Experience supporting clinical-stage programs
- Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
- Familiarity with aggregate reporting and signal detection processes
- Experience in oncology, cell therapy, or gene therapy preferred
Benefits
Comp & perks- Competitive Medical, Dental, and Vision plans
- 401k plan with 100% match up to first 4% deferral
- Generous Paid Time Off policy
- Employee commuter benefits
- Cell phone stipend