Assistant Director, Pharmacovigilance Quality Management, Global Patient Safety

About the role

Argenx is looking for an Assistant Director for Pharmacovigilance Quality Management within its Global Patient Safety (GPS) function. The role is responsible for the operational implementation of the Pharmacovigilance Quality Management System (QMS) in a consistent, effective and efficient way, and for overseeing the management and operational maintenance of third-party contractual obligations. It reports to the Director, GPS Quality Management.

Key responsibilities

• Drive the growth of the GPS Quality Management function and implement the comprehensive training program.
• Manage GPS procedural documents and coordinate audit and inspection readiness, support and management.
• Drive continuous improvement: issue management, process improvement and KPI development.
• Support and monitor compliance with pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements with business partners.
• Delegate GPS QM activities to other GPS QM team members in collaboration with the Director, GPS Quality Management.
• Internal audit and inspection: coordinate GVP audit and inspection activities, prepare the team for inspections, ensure documents are ready, and respond to findings.
• Deviation and CAPA: assess issue management trends, identify internal deviations, lead the team in determining corrective and preventive actions and root causes, and implement actions with the Quality functional area.
• Training and records: develop and deliver the PV training program, update curricula, train employees and third parties, and manage procedural documents, including using the Veeva system for document control.
• Performance and compliance: develop and evaluate KPIs, monitor compliance with third-party obligations and SOPs, and liaise with the QA department.
• Other tasks assigned by the line manager or GPS leadership.

Required profile

• Bachelor's degree in pharmacy, nursing, healthcare or another life-science or technical field, or an equivalent combination of education and experience.
• At least 10 years of experience in the pharmaceutical or biotech industry, with at least 5 years in pharmacovigilance or drug safety.
• Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams.
• Solid experience preparing for, hosting and responding to audits and regulatory inspections globally.
• Working knowledge of pharmacovigilance regulations (Europe, US, Japan) and expert knowledge of GXP quality and compliance requirements.
• Fluency in written and spoken English; candidates must be based in Belgium, Switzerland or the US (EST time zone).

Required skills

• Excellent planning, organizational, oral and written communication, and presentation skills.
• Ability to work in a global environment, independently and with multidisciplinary teams.
• Professional-level computer skills, including tracking systems and presentation software.
• Ability to author and contribute to procedural documents.