argenx

United in our commitment to improve the lives of patients

Director, Safety Data – Systems

Full TimeRemoteTeam 1,001-5,000Since 2008H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

54 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.

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