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.
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