Staff Engineer, Pharmacovigilance
Nagarro
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇳 India
Visit company websiteJob Level
Lead
About the role
- 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
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
Benefits
- Flexible work arrangements
- Dynamic and non-hierarchical work culture
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Argus Safetychange managementchange impact assessmentssystem configurationsworkflowsintegrationsGxP compliancevalidationdocumentationPharmacovigilance
Soft skills
client-facing communicationstakeholder managementorganizational skillsinterpersonal skillsleadership