Job Description
Job Description
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.
Apply for this Position
Ready to join ? Click the button below to submit your application.
Submit Application