Associate Director Global Patient Safety - PV Quality Management

Associate Director Global Patient Safety - PV Quality Management

argenx

Ghent, Belgium or Remote, Switzerland

ROLES AND RESPONSIBILITIES

GPV internal Audit program and Inspection activities:

• Coordinate and manage GVP Audit & Inspection activities.
• Actively engage in internal global GVP audit program and inspection readiness activities in collaboration with the argenx Quality functional area.
• Prepare GPS team members on inspection readiness activities.
• Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
• Coordinate and prepare the GPS responses to audit and inspection findings.

Deviation & Corrective and Preventive Action (CAPA) activities:

• Assess GPS issue management trends and develop/implement actions plans to mitigate systemic causes.
• Identify internal deviations and lead GPS team in determining corrective and preventive actions.
• Guide the GPS team to determine root cause of issue to avoid recurrence.
• In collaboration with the argenx Quality functional area, lead the implementation of corrective or preventive actions.

Training, Procedural Document, & Record Management activities:

• Develop and implement the Pharmacovigilance training program.
• Develop, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc.).
• Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
• Coordinate the monitoring, maintaining, re-evaluating and updating the GPS training curricula.
• Provide training to relevant argenx employees and 3rd parties (when applicable).
• Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.
• Proactively engage in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
• Support document control through use of Veeva System.
• Resolve vendor questions and escalate issues to relevant GPS staff as appropriate.

GPS Performance & Compliance activities:

• Coordinate development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.
• Monitor compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff.
• Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables.
• Monitor the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
• Coordinate the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners.

Other Activities:

• Perform other tasks and duties as assigned by line manager or GPS Leadership.

SKILLS AND COMPETENCIES

• Excellent planning and organizational skills.
• Excellent oral and written communication skills.
• Ability to work in global environment.
• Solution oriented with ability to prioritize and work independently.
• Excellent presentation skills with the 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, presentation software.
• Fluency in written and spoken English.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience.
• At least 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in relevant pharmacovigilance/drug safety field.
• Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams.
• Robust experience with preparing for, hosting and responding to audits and regulatory inspections globally.
• Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan).
• Expert knowledge of GXP quality and compliance requirements, processes and measures.