TL;DR
Staff Engineer, Argus Change Management Support Lead (Pharmacovigilance): Lead and manage Argus Safety system change requests in a GxP-regulated environment with an accent on change impact assessments for system configurations, workflows, and integrations. Focus on maintaining system documentation, ensuring compliance with GxP standards, and supporting audit readiness.
Company
hirify.global is a Digital Product Engineering company that builds products, services, and experiences.
What you will do
- Lead and manage Argus Safety system change requests in a GxP-regulated environment.
- Perform and document change impact assessments for system configurations, workflows, and integrations.
- Coordinate change control activities with business, IT, Quality, and Compliance teams.
- Maintain and update system documentation, including configuration documents, change records, and approvals.
- Support audit and inspection readiness by providing required change and compliance documentation.
- Act as a client-facing SPOC for change management and documentation discussions.
Requirements
- 7+ years of total experience.
- Strong working experience in the Pharmacovigilance (PV) domain.
- Strong understanding of ICSR workflows and drug safety processes.
- Hands-on experience or strong exposure to Oracle Argus Safety.
- Experience or integration awareness of Axway / Safety Gateway.
- Proven expertise in Change Management / Change Control within regulated systems.
Qualifications
- Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
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