argenx
United in our commitment to improve the lives of patients
Director, Safety Data – Systems
Location
United States
Posted
55 days ago
Salary
Not specified
Bachelor Degree10 yrs expEnglish
Job Description
• 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
• Complete additional task and projects as assigned by line manager or Head of GPS
Job Requirements
- 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
- 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.