Director, Safety Data – Systems
argenx
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
safety database managementsystem validationprocedural document developmentpharmacovigilancedata managementclinical researchrisk assessmenttechnology implementationdashboard usagetracking systems
Soft skills
collaborationcommunicationleadershiporganizational skillstrainingteam coordinationproblem-solvingadaptabilityattention to detailproject management