Staff Engineer, Pharmacovigilance
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Job Location:
Any - India
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Department:
Engineering
Job Summary
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.
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 :
Bachelors or masters degree in computer science Information Technology or a related field.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Computer Science
- Docker
- Kubernetes
- Python
- VMware
- C/C++
- Go
- System Architecture
- gRPC
- OS Kernels
- Perl
- Distributed Systems
About Company
Nagarro helps future-proof your business through a forward-thinking, fluidic, and CARING mindset. We excel at digital engineering and help our clients become human-centric, digital-first organizations, augmenting their ability to be responsive, efficient, intimate, creative, and susta ... View more
