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Executive Director – Safety Operations
BeOne MedicinesExecutive Director responsible for global safety operations at BeOne. Ensuring compliance, oversight, and continuous improvement in clinical trials and PV activities.
About the role
Key responsibilities & impact- Ensure end-to-end execution, quality and continuous improvement of global safety operations activities
- Oversee effective collection, processing, assessment and reporting of ICSRs against global standards
- Oversee safety operations activities in clinical trials, as well as China PV activities
- Oversee safety systems and reporting activities
- Actively influence GPS’ operational technology strategy
- Provide broad and deep technical knowledge
- Support and contribute to internal GPS department development
- Liaise cross-functionally to execute on PV responsibilities
- Create resource requirement projections for safety operations
- Recruit, retain, develop, and mentor safety operations staff
- Contribute to audits and inspections
- Monitor drug safety information communication and ensure timely communication
Requirements
What you’ll need- MD, PharmD, RN plus higher degree or international equivalent, or equivalent combination of relevant education or professional experience
- Mastery of global safety regulatory requirements
- Fifteen (15) years relevant experience, including training
- Ten (10) years drug safety experience
- Proficiency in safety report processing & operational systems
- Proficiency of signal recognition, statistical techniques & trials methods & outputs
- Previous management experience
- Process and systems management experience preferred
- Clinical experience preferred
Benefits
Comp & perks- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Signal RecognitionStatistical TechniquesClinical Trials MethodsSafety Report ProcessingOperational Systems Proficiency
Soft Skills
MentoringCross-Functional LiaisonContinuous Improvement
Certifications
MDPharmDRN