argenx · 1 day ago
Director, Safety Data & Systems
United States
Full-time
Remote
Director/Executive
10+ years expargenx is a biotech company focused on transforming immunology and delivering medicines for autoimmune patients. The Director, Safety Data & Systems oversees Global Patient Safety operations, ensuring high quality data management and compliance with regulatory requirements.
BiotechnologyClinical TrialsTherapeutics
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
Qualification
Required
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
Benefits
Short-term and long-term incentive programs
Retirement savings plans
Health benefits
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
H1B Sponsorship
argenx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2023 (5)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$3.75BKey Investors
Forbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M
Leadership Team
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
belganewsagency.eu
2026-01-07
Pharma Letter
2026-01-07
BioWorld Financial Watch
2026-01-07
Company data provided by crunchbase