Director, Safety Data & Systems

argenx

2d • Remote

About The Position

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Director, Safety Data & Systems, GPS Operations oversees and coordinates deliverables related to Global Patient Safety (GPS) Safety Data Management and Safety Systems Maintenance, and ensures high quality data provision for Safety Signal Management, Risk Management and Safety Evidence generation. The Director will also collaborate and co-create within argenx as well as with Safety vendors and argenx business partners, and ensure compliance with regulatory requirements regarding Safety data processing and reporting with high technical and operational standards.

Requirements

• Advanced knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
• Advanced computer skills in all current office applications including PowerPoint, Visio
• Expert level skill in Excel usage required, experience with SQL is a plus
• Advanced proficiency in Safety Database systems (e.g. Argus) and other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems).
• Advanced proficiency in electronic systems and dashboards commonly used for data visualization and analysis
• Knowledge of workflow based case processing and the MedDRA dictionary
• Robust understanding of the quality management processes, metrics and KPIs
• Advanced project management skills to complete multiple complex deliverables within tight timelines
• Proven ability to communicate effectively and collaborate successfully across functions and with vendors
• Fluent communication in written and spoken English required
• Proven ability to work independently with minimal oversight and prioritize effectively
• Ability to function effectively in a team environment
• Ability to assume Line Management responsibility and oversee functional teams
• At least Bachelors’ degree (or country equivalent) in life sciences / Information technology or other relevant field required
• Minimum of 10 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 5 years of proven experience working in Safety database setup and maintenance.
• Proven experience of the usage of advanced technology and tools (tracking systems, dashboards) used in Safety / PV, pre-and post-marketing.
• Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills.

Responsibilities

• Oversee and coordinate the maintenance of and updates to the global safety database for all argenx products, new programs including reporting rules and system validation
• Lead GPS collaboration with Safety vendor on initial and ongoing Safety database configurations and assess impact and risk on changes applied
• Develop and implement procedural documents such as Job Aides, Work instructions, forms and templates related to safety data management and systems maintenance
• Collaborate and co-create with global argenx functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical roadmap, setup and operations
• Keep team and self updated on applicable regulatory and PV tech guidelines and regulations and provide targeted trainings as applicable
• Focus areas would be but not limited to Safety operations and process optimization, Vendor management and third-party oversight, Drug safety database and systems administration, Regulatory inspections/audits and quality compliance and Cross-functional collaboration for risk management and reporting.
• Complete additional task and projects as assigned by line manager or Head of GPS

Benefits

• This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies.
• It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees