Job Title
Safety Systems Manager – Argus SME
Location
Pune, India
Employment Type
Full-time
Job Requisition ID
261249
Application Deadline
May 25, 2026
Role Overview
The Safety Systems Manager – Argus SME is responsible for overseeing pharmacovigilance (PV) safety systems implementation, support, configuration, migration, and operational management. This role combines technical expertise, project management, compliance oversight, stakeholder management, and team leadership.
The position acts as a Subject Matter Expert (SME) for drug safety systems such as Argus, ARISg, and Veeva, while also supporting system strategy, process improvements, vendor management, release management, and end-user support activities.
Key Responsibilities
1. Safety Systems Management
Support implementation, configuration, maintenance, and migration of PV safety systems
Provide technical and operational support to internal and external clients
Manage operation and maintenance of critical IT systems across departments
Lead end-to-end release management activities for safety systems
Conduct periodic system evaluations and compliance reviews
2. Argus SME & Technical Leadership
Serve as Subject Matter Expert (SME) for:
Argus
ARISg
Veeva
Other drug safety systems
Provide guidance on:
Safety system reporting
Advanced query conditions
Standard MedDRA Queries (SMQ)
Support technical planning for complex global and multi-study projects
Provide technical support and mentorship to team members
3. Business Analysis & Strategy
Conduct technical impact analysis for proposed software/system changes
Assess business value and contribute to strategic decision-making
Gather and document business and user requirements
Collaborate with technology partners to ensure timely delivery of requirements
Develop IT system strategies and enterprise architecture recommendations
4. Reporting & Data Management
Develop standard and ad hoc reports from safety systems
Support data migration activities and migration documentation
Perform User Acceptance Testing (UAT) and maintain related documentation
Monitor system failures and resolve issues promptly
5. Compliance & Quality Management
Ensure adherence to:
SOPs
PV regulations
Compliance standards
Quality requirements
Update departmental:
SOPs
Working practices
Guidelines
Identify opportunities to improve compliance, quality, and operational efficiency
6. Training & Change Management
Support change management initiatives
Collaborate with training teams to develop safety-system-specific training modules
Train team members on technical and functional system aspects
Support end users and sponsors with system-related guidance
7. Project & Stakeholder Management
Manage project activities and client communications
Represent the systems team in:
Internal meetings
Client meetings
Audits
Coordinate with stakeholders and vendors to ensure deliverables meet agreed timelines and service levels
Track project timelines, budgets, and quality metrics
8. Team Leadership & Resource Management
Lead critical team projects
Manage team workload and resource allocation
Oversee:
New hires
Transfers
Contractors
Terminations
Conduct:
Performance management
Employee development
Administrative and disciplinary activities
Encourage staff career growth and development
9. Process Improvement & Innovation
Contribute to improvements in:
Programming methodologies
Documentation standards
System processes
Share technical expertise during departmental meetings
Stay updated on:
Industry trends
Regulatory changes
New safety system tools and practices
Required Qualifications
Education
Bachelor’s degree in:
Life Sciences
IT / Computer Science
Related field
Equivalent relevant experience may be considered in place of formal education.
Required Experience
8+ years of experience with drug safety systems such as:
Argus
ARISg
Veeva
Experience in systems operations support
Experience with validated document management systems
Experience managing technical projects and client communications
Required Skills
Technical Skills
Strong understanding of:
PV safety systems
System integration
Release management
Compliance management
Good knowledge of Microsoft Office tools
Management & Leadership Skills
Change Management
Customer Relationship Management (CRM)
Vendor Management
People Management
Stakeholder Management
Core Competencies
Strong analytical and problem-solving skills
Excellent written and verbal communication
Ability to prioritize and manage multiple tasks
Strong attention to detail
Team collaboration and mentoring capability
Preferred Qualifications
Clinical background with experience using clinical systems
Good understanding of SQL programming language
Work Environment
Office-based environment
Cross-functional and global collaboration setting
High-compliance and technology-driven workplace
Compliance & Safety Requirements
Employees are expected to comply with:
Health and Safety at Work Act 1974
COSHH Regulations 1989
EC Directives 1992/3
Company Health & Safety policies and procedures
Role Summary
The Safety Systems Manager – Argus SME is a senior-level leadership role responsible for managing pharmacovigilance safety systems, driving technical and operational excellence, overseeing compliance and release management, and leading cross-functional teams. The role requires strong expertise in Argus and related PV systems, along with project management, stakeholder engagement, and people leadership capabilities.
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