Safety Operations Manager, Global Patient Safety
argenx
argenx seeks a Safety Operations Manager to oversee global patient safety operations, coordinating with internal teams and external vendors on pharmacovigilance case processing and regulatory compliance. The role reports to the Director of Global Patient Safety Operations and involves managing safety deliverables across multiple regions.
Responsibilities
- Oversee case triage, processing, and expedited and aggregate reporting with safety vendors
- Coordinate with clinical, medical, regulatory teams and external parties on safety deliverables
- Manage Safety Specialist tasks and monitor timely GPS communications
- Develop and implement new safety processes and procedures across operations
- Identify operational issues and escalate risks while ensuring regulatory compliance
Requirements
- Bachelor's or Master's degree in nursing, healthcare, or life sciences
- Minimum 7 years of global pharmacovigilance experience in EU and US markets
- Advanced knowledge of medical terminology, PV processes, and global regulatory requirements
- Proficiency with safety database systems, particularly ARGUS, and MedDRA coding
- Advanced Excel, PowerPoint, and Visio skills with strong written and spoken English
- Proven experience managing third-party vendors and identifying quality issues
- Located in Belgium, Switzerland, or US (EST time zone)
L'offre d'emploi a été publiée il y a 7 jours
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