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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in global safety operations, including drug safety experience and proficiency in safety report processing. Capable of leading cross-functional teams, mentoring staff, and ensuring compliance with regulatory requirements.
Highest-signal resume keywords
Global Safety Regulatory Requirements MasteryFifteen Years Relevant ExperienceTen Years Drug Safety ExperienceSafety Report Processing ProficiencyManagement Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Signal RecognitionStatistical TechniquesClinical Trials MethodsSafety Report ProcessingOperational Systems Proficiency
Soft Skills
MentoringCross-Functional LiaisonContinuous Improvement
Certifications & Qualifications
MDPharmDRN
Industry Keywords
Drug SafetyPharmacovigilanceClinical TrialsSafety OperationsAudits and Inspections
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