Global Safety Operations Leader

argenx SE; Oost-Vlaanderen; On-site; EUR 90,000 - 150,000; Full time

Job summary

argenx is seeking a seasoned professional to oversee Global Patient Safety Operations, coordinating with vendors and GPS teams worldwide to ensure compliant, timely case processing and reporting. The role collaborates with clinical, medical and regulatory functions to deliver safety deliverables and manage PV agreements.

Ideal candidates bring 7+ years in global PV with ARGUS experience, strong English communication, and a track record of process improvement within regulated environments.

Qualifications

• Bachelor’s or Master’s degree in nursing, healthcare or life sciences
• Minimum 5 years in Safety/Clinical Research/Pharmacovigilance
• 7+ years in global pharmacovigilance/drug safety (EU/US)
• Advanced expertise of global PV requirements and practices
• Proven experience with safety database systems (ARGUS preferred) including workflow management
• Experience with interaction with 3rd party vendors
• Located in Belgium, Switzerland or US (EST time zone) to be considered for this role.

Responsibilities

• Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
• Coordinates with GPS GSL team in relations to case processing
• Collaborates with clinical, medical, regulatory teams and external parties regarding safety deliverables and processes
• Communicates safety deliverables within argenx and with distributors regarding PV Agreements / SDEA
• Oversees assignment of Safety Specialist tasks and timely monitoring of GPS communications
• Identifies issues and areas for improvement and escalates appropriately
• Leads development and implementation of new processes and procedures
• Performs activities in compliance with argenx procedures and global/local regulations

Skills

Pharmacovigilance expertise

Cross-functional collaboration

English communication

Risk identification and mitigation

Safety process improvement

Education

Bachelor’s or Master’s degree in nursing, healthcare or life sciences

7+ years in global PV/drug safety

Tools

ARGUS proficiency

Microsoft Office (Excel, PowerPoint, Visio)

Job description

argenx is seeking a seasoned professional to oversee Global Patient Safety Operations, coordinating with vendors and GPS teams worldwide to ensure compliant, timely case processing and reporting. The role collaborates with clinical, medical and regulatory functions to deliver safety deliverables and manage PV agreements.

Ideal candidates bring 7+ years in global PV with ARGUS experience, strong English communication, and a track record of process improvement within regulated environments.