Safety Operations Manager, Global Patient Safety

• Oversee operational delivery and staff within Global Patient Safety Operations in accordance with GPS vision, strategy, and regulatory requirements
• Guide internal functions and external vendors to support seamless GPS Operations
• Oversee and coordinate safety vendor and GPS teams for case triage and processing, expedited reporting, and aggregate reporting
• Coordinate with and support GPS GSL team deliverables related to case processing
• Collaborate with clinical, medical, regulatory, and other internal teams, as well as healthcare professionals, consumers, and contracted resources
• Communicate with argenx, business partners, and distributors regarding Pharmacovigilance Agreements and Safety Data Exchange Agreements
• Oversee assignment of Safety Specialist tasks and timely monitoring of GPS communications
• Identify issues and improvement opportunities and escalate appropriately
• Develop new processes and procedures and lead their implementation
• Perform activities in compliance with argenx Controlled Procedures and applicable global and local regulations
• Perform other tasks assigned by the line manager or Head of GPS

• Advanced knowledge of medical terminology, pharmacovigilance processes, and relevant global regulations, including EU, US, and Japan requirements
• Strong background/experience in post-marketing pharmacovigilance and global reporting requirements
• Proficiency with safety database systems, including Argus, and MedDRA coding
• Advanced computer skills, including Microsoft Office, Excel, PowerPoint, and Visio
• Advanced written and spoken English
• Experience participating in Health Authority inspections is advantageous
• Bachelor’s/Master’s degree or local equivalent in nursing, healthcare, life sciences, or a relevant field
• Minimum of 5 years of relevant experience in Safety, Clinical Research, or Pharmacovigilance
• At least 7 years of relevant experience in global pharmacovigilance/drug safety in the EU and US
• Equivalent and adequate combination of education and experience
• Advanced expertise in global EU/US pharmacovigilance requirements and practices
• Advanced experience with safety database systems, preferably ARGUS, including workflow management
• Proven experience interacting with third-party vendors
• Proven experience identifying quality issues and evaluating quality metrics
• Must be located in Belgium, Switzerland, or the US (EST time zone)

• Short-term incentives program
• Long-term incentives program
• Inclusive environment
• Equal consideration for employment without discrimination