At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.
Requirements
- Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
- Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
- Assist with data reconciliation and support safety signal management and aggregate data review activities
- Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
- Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
- Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
- Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
- Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
- Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
- Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions
- Support the development and maintenance of inspection readiness activities, identify and participate in process improvement initiatives
- Assist in GCP and GVP inspection readiness and support audits
Benefits
- Comprehensive health benefits
- Tax-advantaged savings accounts
- Flexible time off
- 13 paid holidays
- Companywide year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Disability and life insurance
