Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Nagarro
Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Job Description
Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Location: WFA/Remote, India | Job ID: REF55198J
Role 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.
Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
Key Responsibilities
- Lead and manage Argus Safety system change requests in GxP-regulated environment
- Perform and document change impact assessments for configurations, workflows, and integrations
- Coordinate change control with business, IT, Quality, and Compliance teams
- Ensure changes follow GxP-compliant processes and maintain inspection-ready documentation
- Support audit/inspection readiness and provide compliance documentation
- Act as client-facing SPOC for change management discussions
- Conduct periodic system and user access reviews
What You Bring (Qualifications)
- Total experience 7+ years
- Strong working experience in Pharmacovigilance (PV) domain
- Hands-on experience with Oracle Argus Safety
- Bachelor’s or master’s degree in computer science, Information Technology, or related field
- Experience supporting audits and inspections
Core Skills
Oracle Argus Safety, Pharmacovigilance (PV) domain, ICSR workflows and drug safety processes, Change Management / Change Control, GxP, CSV, validation lifecycle, SQL for data validation, Stakeholder management and leadership, Axway / Safety Gateway integration
Why Nagarro? (Benefits)
- Caring mindset with emphasis on work-life balance and employee well-being
- Fluidic Enterprise model offering flexibility and agile career growth
- Global opportunities across 30+ countries and diverse projects
- Remote/WFA options supporting work from anywhere in India
- Collaborative culture fostering leadership and stakeholder impact
- Professional development in cutting-edge digital engineering
Locations
- WFA/Remote, India
Salary
Salary details available upon request
2,500,000 - 4,860,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Oracle Argus Safetyintermediate
- Pharmacovigilance (PV) domainintermediate
- ICSR workflows and drug safety processesintermediate
- Change Management / Change Controlintermediate
- GxP, CSV, validation lifecycleintermediate
- SQL for data validationintermediate
- Stakeholder management and leadershipintermediate
- Axway / Safety Gateway integrationintermediate
Required Qualifications
- Total experience 7+ years (experience)
- Strong working experience in Pharmacovigilance (PV) domain (experience)
- Hands-on experience with Oracle Argus Safety (experience)
- Bachelor’s or master’s degree in computer science, Information Technology, or related field (experience)
- Experience supporting audits and inspections (experience)
Responsibilities
- Lead and manage Argus Safety system change requests in GxP-regulated environment
- Perform and document change impact assessments for configurations, workflows, and integrations
- Coordinate change control with business, IT, Quality, and Compliance teams
- Ensure changes follow GxP-compliant processes and maintain inspection-ready documentation
- Support audit/inspection readiness and provide compliance documentation
- Act as client-facing SPOC for change management discussions
- Conduct periodic system and user access reviews
Benefits
- general: Caring mindset with emphasis on work-life balance and employee well-being
- general: Fluidic Enterprise model offering flexibility and agile career growth
- general: Global opportunities across 30+ countries and diverse projects
- general: Remote/WFA options supporting work from anywhere in India
- general: Collaborative culture fostering leadership and stakeholder impact
- general: Professional development in cutting-edge digital engineering
Tags & Categories
Answer 10 quick questions to check your fit for Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro @ Nagarro.
Related Books and Jobs
Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Nagarro
Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Job Description
Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro
Location: WFA/Remote, India | Job ID: REF55198J
Role 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.
Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
Key Responsibilities
- Lead and manage Argus Safety system change requests in GxP-regulated environment
- Perform and document change impact assessments for configurations, workflows, and integrations
- Coordinate change control with business, IT, Quality, and Compliance teams
- Ensure changes follow GxP-compliant processes and maintain inspection-ready documentation
- Support audit/inspection readiness and provide compliance documentation
- Act as client-facing SPOC for change management discussions
- Conduct periodic system and user access reviews
What You Bring (Qualifications)
- Total experience 7+ years
- Strong working experience in Pharmacovigilance (PV) domain
- Hands-on experience with Oracle Argus Safety
- Bachelor’s or master’s degree in computer science, Information Technology, or related field
- Experience supporting audits and inspections
Core Skills
Oracle Argus Safety, Pharmacovigilance (PV) domain, ICSR workflows and drug safety processes, Change Management / Change Control, GxP, CSV, validation lifecycle, SQL for data validation, Stakeholder management and leadership, Axway / Safety Gateway integration
Why Nagarro? (Benefits)
- Caring mindset with emphasis on work-life balance and employee well-being
- Fluidic Enterprise model offering flexibility and agile career growth
- Global opportunities across 30+ countries and diverse projects
- Remote/WFA options supporting work from anywhere in India
- Collaborative culture fostering leadership and stakeholder impact
- Professional development in cutting-edge digital engineering
Locations
- WFA/Remote, India
Salary
Salary details available upon request
2,500,000 - 4,860,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Oracle Argus Safetyintermediate
- Pharmacovigilance (PV) domainintermediate
- ICSR workflows and drug safety processesintermediate
- Change Management / Change Controlintermediate
- GxP, CSV, validation lifecycleintermediate
- SQL for data validationintermediate
- Stakeholder management and leadershipintermediate
- Axway / Safety Gateway integrationintermediate
Required Qualifications
- Total experience 7+ years (experience)
- Strong working experience in Pharmacovigilance (PV) domain (experience)
- Hands-on experience with Oracle Argus Safety (experience)
- Bachelor’s or master’s degree in computer science, Information Technology, or related field (experience)
- Experience supporting audits and inspections (experience)
Responsibilities
- Lead and manage Argus Safety system change requests in GxP-regulated environment
- Perform and document change impact assessments for configurations, workflows, and integrations
- Coordinate change control with business, IT, Quality, and Compliance teams
- Ensure changes follow GxP-compliant processes and maintain inspection-ready documentation
- Support audit/inspection readiness and provide compliance documentation
- Act as client-facing SPOC for change management discussions
- Conduct periodic system and user access reviews
Benefits
- general: Caring mindset with emphasis on work-life balance and employee well-being
- general: Fluidic Enterprise model offering flexibility and agile career growth
- general: Global opportunities across 30+ countries and diverse projects
- general: Remote/WFA options supporting work from anywhere in India
- general: Collaborative culture fostering leadership and stakeholder impact
- general: Professional development in cutting-edge digital engineering
Tags & Categories
Answer 10 quick questions to check your fit for Staff Engineer, Argus Change Management Support Lead - Careers at Nagarro @ Nagarro.
Related Books and Jobs