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Company

argenx · 4 hours ago

Senior Director, Safety Data and Systems

Boston, MA

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

15+ years exp

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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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Safety Database systemsSafety Signalling systemsPharmacovigilance regulatory requirementsSQL programming queriesClinical Research systemsData visualization toolsProject managementManagement experienceOffice applicationsQuality management processes

Required

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

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