Nagarro

Staff Engineer, Argus Change Management Support Lead

Nagarro Remote Today
engineering

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.

Qualifications

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

About the Company

👋🏼We're Nagarro.

We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale — across all devices and digital mediums, and our people exist everywhere in the world (17700+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We're looking for great new colleagues. That's where you come in!

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