Ass. Dir. Pharmacovigilance Quality Management, Global Patient Safety

argenx

About The Position

The Global Patient Safety (GPS) Pharmacovigilance Quality Management Lead is responsible for operationally implementing the Pharmacovigilance Quality Management System consistently, effectively, and efficiently within the Global Patient Safety function. The role provides pharmacovigilance oversight for managing and maintaining third-party contractual obligations and supports the growth of the GPS Quality Management function. The position drives implementation of a comprehensive training program, manages GPS procedural document activities, and coordinates audit and inspection readiness, support, and management. It also advances continuous improvement through issue management, process improvement, and KPI development. The role supports or manages the development and compliance monitoring of pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and other applicable business-partner agreements. It supports, guides, and delegates GPS QM activities to other team members in collaboration with the Director, GPS Quality Management. Candidates must be based in Belgium, Switzerland, or the US Eastern Time Zone. The role is eligible to participate in short-term and long-term incentive programs. The recruiter will share the locally applicable annual base salary hiring range during the recruitment process.

Requirements

At least a bachelor's degree in pharmacy, nursing, healthcare, another life-science or technical field, or a country-equivalent combination of education and experience.
At least 10 years of experience in the pharmaceutical or biotechnology industry, including at least 5 years in a relevant pharmacovigilance or drug-safety field.
Proven track record of establishing or managing pharmacovigilance quality systems, processes, and teams.
Substantial experience preparing for, hosting, and responding to audits and regulatory inspections globally.
Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance, including those applicable in Europe, the US, and Japan.
Expert knowledge of GxP quality and compliance requirements, processes, and measures.
Excellent planning and organizational skills.
Excellent oral and written communication skills and fluency in written and spoken English.
Ability to work in a global environment, prioritize, work independently, and take a solution-oriented approach.
Excellent presentation skills and ability to communicate complex issues clearly.
Demonstrated ability to author and contribute to procedural documents.
Ability to motivate, influence, and collaborate with multidisciplinary teams.
Professional-level computer skills, including proficiency with tracking systems and presentation software.
Must be based in Belgium, Switzerland, or the US Eastern Time Zone.

Responsibilities

Coordinate and manage Good Pharmacovigilance Practices (GVP) audit and inspection activities.
Participate in the internal global GVP audit program and inspection-readiness activities in collaboration with the Quality function.
Prepare GPS team members for inspections and ensure relevant documents and contact information are readily retrievable and up to date.
Coordinate and prepare GPS responses to audit and inspection findings.
Assess GPS issue-management trends and develop and implement action plans to mitigate systemic causes.
Identify internal deviations, lead the GPS team in determining corrective and preventive actions, and guide root-cause analysis to prevent recurrence.
Lead implementation of corrective and preventive actions in collaboration with the Quality function.
Develop, expand, and deliver the pharmacovigilance training program, including training on procedural documents, inspection readiness, and refresher topics.
Work with stakeholders to support or implement pharmacovigilance training across the organization; maintain, evaluate, and update GPS training curricula; and train relevant employees and third parties when applicable.
Manage GPS procedural-document activities, including contributing to, developing, reviewing, and continually improving GPS processes and procedures.
Participate in cross-functional procedural-document activities to determine relevance to GPS and ensure appropriate GPS input and review.
Support document control using the Veeva system; resolve vendor questions and escalate issues to relevant GPS staff as appropriate.
Coordinate the development and evaluation of Key Performance Indicators and adapt them to evolving business needs.
Monitor compliance with third-party contractual obligations and PVAs, identify gaps or non-conformities, and report them appropriately to GPS staff.
Liaise with the QA Department regarding GPS quality and compliance requirements and deliverables.
Monitor the status of and compliance with GPS Standard Operating Procedures and other controlled documents.
Coordinate development and compliance monitoring of PVAs, SDEAs, and other applicable agreements with business partners.
Support, guide, and delegate GPS Quality Management activities to other GPS QM team members in collaboration with the Director, GPS Quality Management.
Perform other tasks and duties assigned by the line manager or GPS Leadership.