Staff Engineer, Argus Change Management Support Lead

REQUIREMENTS:

• Total experience 7+ years.
• 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.
• Solid understanding of GxP, CSV, validation lifecycle, and controlled documentation practices.
• Experience supporting audits and inspections.
• SQL basics for data validation, reconciliation, and reporting support.
• Excellent client-facing communication, stakeholder management, and leadership skills.

RESPONSIBILITIES:

• 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.
• Ensure all system changes follow approved GxP-compliant change management processes.
• Maintain and update system documentation, including configuration documents, change records, and approvals.
• Conduct periodic system and user access reviews and document outcomes.
• Ensure documentation is accurate, traceable, and inspection-ready always.
• Support audit and inspection readiness, providing required change and compliance documentation.
• Review and support deviations, CAPAs, and documentation updates related to system changes.
• Act as a client-facing SPOC for change management and documentation discussions.
• Communicate change status, impacts, and approvals to key stakeholders.

Bachelor’s or master’s degree in computer science, Information Technology, or a related field.