Staff Engineer, Pharmacovigilance

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.

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