Chief Data Officer, Safety Systems

3 weeks ago

Étreux, Hauts-de-France, United States argenx Full time

Estimated annual salary: $180,000 - $220,000.

About argenx

argenx is a biotech company that transforms immunology to deliver medicines for autoimmune patients. We are expanding our pipeline of differentiated assets, led by VYVGART, a first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and potential treatments for dozens of severe autoimmune diseases.

We strive to innovate across all corners of our business, inspiring and growing our company, partnerships, science, and people. When we do, we deliver more for patients.

Job Description

The Chief Data Officer, Safety Systems will oversee GPS Safety Signal Management and Safety Risk Management deliverables. This role will lead and manage the execution of GPS Safety Data Management and System Maintenance initiatives, driving continuous improvement and operational excellence.

This position reports to the Head of Global Patient Safety Operations and facilitates cross-functional collaboration across GPS and key departments, including Business Information Systems (BIS), Quality, and Regulatory Affairs.

The successful candidate will develop and implement innovative solutions to drive efficiency and highest quality standards.

Key Responsibilities:
  • Collaborate with GPS functional areas to evaluate opportunities for technology-based process improvements.
  • Partner with Quality functions to ensure compliance with applicable quality and validation standards.
  • Represent GPS Safety Systems in interactions with applicable argenx functions regarding pharmacovigilance technical roadmap, setup, and operation.
  • Provide expert technical and operational guidance to safety vendors and internal staff.
  • Support GPS business owners of pharmacovigilance systems and assume the business owner role when designated, driving continuous system enhancement and operational support.
  • Oversee and guide GPS collaboration with Safety vendor on safety database upgrades and major Safety database configuration changes.
  • Direct the development and maintenance of safety database queries, safety analysis, and tracking tools.
  • Lead the development and implementation of procedural documents such as SOPs, Work Instructions, job aides, and other documents and conventions as applicable.
  • Maintain advanced expertise on applicable regulatory and PV tech guidelines and share with GPS team members as applicable.
Requirements:
  • Advanced proficiency in Safety Database systems (Argus) and Safety Signalling systems (Empirica) as well as other technical systems applicable to Safety / Pharmacovigilance.
  • Advanced working knowledge of relevant global pharmacovigilance regulatory requirements and guidance documents.
  • Advanced computer skills in all current office applications.
  • Expert level skill in Excel usage required.
  • Expertise in writing and validating SQL programming queries required.
  • Robust proficiency in electronic systems commonly used for Clinical Research and various data visualization and analysis tools, dashboards.
  • Robust understanding of the quality management processes, metrics, and KPIs.
  • Advanced project management skills to complete multiple complex deliverables within tight timelines.
  • Ability to communicate effectively and collaborate successfully across functions and with vendors.
  • Fluent communication in written and spoken English required.
  • Work independently with minimal oversight and prioritize effectively.
  • Effectively function in a team environment.
Education and Experience:
  • At least a Bachelor's degree in life sciences or Information technology or other relevant field required.
  • Minimum of 15 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with 10 years or more of relevant experience in Safety database / signal management systems.
  • Proven experience in PV/Safety Systems technical administration and support including coding and programming.
  • Proven experience in safety data retrieval activities such as development and generation of custom aggregate listings.

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