16h ago
Senior Manager, Global Patient Safety Operations
Redwood City, California
$164k-$205k / year
full-timeseniorbiotech
๐ Tech Stack
๐ผ About This Role
You'll oversee pharmacovigilance operational activities for clinical oncology programs, managing safety data collection and reporting. You'll collaborate with cross-functional teams and PV CROs to ensure regulatory compliance. This role offers the opportunity to shape safety operations at a late-stage clinical company.
๐ฏ What You'll Do
- Manage PV CROs for safety reporting compliance
- Oversee safety database setup and global reporting
- Support authoring protocols, IBs, and aggregate reports
- Collaborate on SAE reconciliation and query resolution
๐ Requirements
- Bachelor's degree in a healthcare field
- 5+ years pharmacovigilance operational experience
- Hands-on CRO/vendor management experience
- Global safety reporting regulations expertise
โจ Nice to Have
- Master's degree in healthcare field
- 7+ years pharmacovigilance experience
- Investigator sponsored trials experience
๐ Benefits & Perks
- ๐ฐ Equity Awards
- ๐๏ธ Hybrid Work Model
- ๐ Learning & Development Opportunities
- ๐ฅ Competitive Benefits Package
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Callยท 30 min
- 2Hiring Manager Interviewยท 45 min
- 3Cross-functional Panelยท 60 min
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