Global Pharmacovigilance Operations Lead

Argenx; Oost-Vlaanderen; On-site; EUR 90,000 - 130,000; Full time

Job summary

argenx is seeking a Senior Global PV Operations leader to oversee GPS Operations, ensure compliant case processing, and coordinate with vendors and internal teams to deliver timely safety data. You will drive process improvements and ensure alignment with global regulatory requirements.

The role requires extensive pharmacovigilance experience (EU/US), deep knowledge of ARGUS, and strong communication skills to interact with clinical, regulatory, and partner organizations.

Qualifications

• Bachelor’s or Master’s degree in nursing, healthcare or life-science.
• Minimum 5 years of experience in Safety/Clinical Research/Pharmacovigilance.
• At least 7 years in global pharmacovigilance/drug safety (EU/US).
• Advanced expertise in EU/US pharmacovigilance requirements and practices.
• Experience with safety databases (ARGUS) and workflow management.
• Proven experience with interaction with 3rd party vendors.
• Ability to identify quality issues and evaluate metrics.

Responsibilities

• Oversees GPS Operations case triage, processing, and reporting.
• Coordinates with GPS teams and external vendors for deliverables.
• Collaborates with clinical, medical, or regulatory teams on safety tasks.
• Communicates with partners regarding PV agreements and data transfers.
• Assigns Safety Specialist tasks and monitors GPS communications.
• Identifies issues, escalates appropriately, and develops new processes.
• Ensures compliance with argenx procedures and global regulations.
• Performs additional tasks as assigned by the line manager or Head of GPS.

Skills

Pharmacovigilance

Medical terminology

Safety database (ARGUS)

MS Office (Excel, PowerPoint, Visio)

English communication

Vendor management

Cross-functional collaboration

Regulatory knowledge (EU/US)

Education

Bachelor/Master in life-science

Equivalent mix of education/experience

Advanced PV knowledge (EU/US)

Tools

ARGUS

MedDRA coding

MS Office (Excel, PowerPoint, Visio)

Job description

argenx is seeking a Senior Global PV Operations leader to oversee GPS Operations, ensure compliant case processing, and coordinate with vendors and internal teams to deliver timely safety data. You will drive process improvements and ensure alignment with global regulatory requirements.

The role requires extensive pharmacovigilance experience (EU/US), deep knowledge of ARGUS, and strong communication skills to interact with clinical, regulatory, and partner organizations.