Staff Engineer, Pharmacovigilance

Nagarro is a Digital Product Engineering company with over 17,700 experts across 39 countries, known for building inspiring products and experiences. The company fosters a dynamic, non-hierarchical culture. This Staff Engineer role in Pharmacovigilance involves leading and managing Argus Safety system change requests in a GxP-regulated environment. Responsibilities include performing change impact assessments, coordinating change control activities with various teams, ensuring GxP compliance, maintaining system documentation, and acting as a client-facing point of contact for change management discussions.

Must Have

• 7+ years total experience
• Hands-on experience in Pharmacovigilance processes, including ICSR lifecycle
• Hands-on experience with Argus Safety for change management and documentation
• Proven expertise in Change Management in regulated (GxP) environments
• Solid understanding of GxP compliance, validation, and documentation expectations
• Excellent client-facing communication and stakeholder management skills
• 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

Company Description

👋🏼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!

Job Description

REQUIREMENTS:

• Total experience 7+ years.
• Hands on working experience in Pharmacovigilance processes, including ICSR lifecycle.
• Hands-on experience with Argus Safety, specifically from a change management and documentation perspective.
• Proven expertise in Change Management within regulated (GxP) environments.
• Solid understanding of GxP compliance, validation, and documentation expectations.
• Excellent client-facing communication and stakeholder management 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.