Lead and manage Argus Safety system change requests in a GxP-regulated environment, ensuring compliance and documentation accuracy. Coordinate activities across teams and act as a client SPOC for change management discussions.
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 DescriptionREQUIREMENTS:
- 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.
Top Skills
Argus Safety
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