Senior Director, Safety Data and Systems

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Senior Director, Safety Data and Systems will oversee and coordinate deliverables related to GPS Safety Signal Management and Safety Risk Management. Additionally, this role will be responsible for lead and managing the execution of GPS Safety Data Management and System Maintenance initiatives, driving continuous improvement and operational excellence.

Reporting to the Head of Global Patient Safety Operations, the Senior Director, Safety Data and Systems will facilitate cross-functional collaboration across GPS and key departments, including Business Information Systems (BIS), Quality, and Regulatory Affairs, to ensure seamless coordination and optimal outcomes. He/she will also lead strategic development and implementation of innovative solution designed to drive efficiency and highest quality standards.

Roles and Responsibilities:

• Collaborate with applicable GPS functional areas to evaluate opportunities for technology based process improvements

• Partner with the Quality functions to ensure compliance with all applicable quality and validation standards

• Represent GPS Safety Systems in interactions with applicable argenx functions (e.g. Quality, Regulatory, Data Management, Business Information Systems, Quantitative Science) in regards to 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 procedural documents such as SOPs and 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

• Get involved in additional task and projects as assigned by line manager or Head of GPS

Skills and Competencies:

• Advanced proficiency in Safety Database systems (Argus) and Safety Signalling systems (Empirica) as well as other technical systems applicable to Safety / Pharmacovigilance (e.g. E2B gateways)

• Advanced working knowledge of relevant global 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

• Expertise in writing and validating SQL programming queries required

• Robust proficiency in electronic systems commonly used for Clinical Research (e.g. EDC, TMF) 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

• Management experience or experience in the oversight of functional teams would be a plus

Education, Experience and Qualifications:

• At least Bachelors’ degree (or country equivalent) in life sciences / 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 including the usage of advanced technology and tools used in the Safety / PV / Medical technology fields

• 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

• Equivalent and adequate combination of education and experience

• A well rounded mix of experience in CRO / Consulting / Pharma / Pre- and Post marketing Safety technology environment would be preferred

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