Lead Argus Safety system change requests in a GxP-regulated environment, ensuring compliance with change management processes and maintaining accurate documentation.
Company Description
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Job DescriptionREQUIREMENTS:
- 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.
Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
Top Skills
Axway
Oracle Argus Safety
SQL
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