Job Title
Safety Systems Manager, Argus SME
Location: Pune
Employment Type: Full-time
Job ID: 261249
Application Deadline: May 25, 2026
Job Overview
The role involves supporting the implementation, configuration, migration, and ongoing maintenance of pharmacovigilance (PV) safety systems. The candidate will act as a Subject Matter Expert (SME), providing technical and functional support across internal and external clients, ensuring compliance with regulatory and company safety standards.
The position requires a strong blend of technical expertise and business understanding in safety systems such as Argus, ARISg, or Veeva.
Key Responsibilities
1. Safety Systems Management & Support
Support implementation, configuration, and migration of safety systems.
Provide system support to internal and external clients.
Monitor system mailbox for failures and resolve issues promptly.
Ensure compliance with regulatory requirements and internal SOPs.
2. Business & Technical Analysis
Evaluate project proposals and software changes for technical and business impact.
Translate business requirements into system deliverables.
Collaborate with stakeholders to gather and document user requirements.
Contribute to system strategy and enterprise architecture decisions.
3. Reporting & Documentation
Develop standard and ad hoc reports from safety systems.
Maintain documentation for system processes, migration, and evaluations.
Update departmental SOPs, guidelines, and working practices.
4. Testing & Validation
Perform User Acceptance Testing (UAT).
Complete validation documentation for system changes and releases.
5. Training & Knowledge Sharing
Support end users and sponsors with system training.
Collaborate with training teams to develop PV system training modules.
Train team members on technical and functional aspects.
6. Project & Release Management
Manage end-to-end system release cycles.
Participate in data migration activities.
Oversee technical planning for complex global projects.
Ensure timely delivery of projects within scope and budget.
7. Stakeholder & Vendor Management
Communicate project status to management and stakeholders.
Coordinate with vendors and ensure deliverables meet agreements.
Represent systems team in internal and client meetings, including audits.
8. Leadership & Team Management
Manage team resources, workload distribution, and performance.
Handle hiring, transfers, and performance evaluations.
Support staff development and career growth.
Ensure efficient utilization of team resources.
9. Continuous Improvement
Improve system processes, methodologies, and documentation.
Stay updated with PV regulations, tools, and industry trends.
Share knowledge within the department.
Required Qualifications
Degree in Life Sciences or IT/Computing.
8+ years of experience in pharmacovigilance safety systems (Argus / ARISg / Veeva).
Experience in systems operations or support roles.
Experience with validated document management systems.
Strong knowledge of Microsoft Office tools.
Good understanding of system integration.
Strong communication and problem-solving skills.
Ability to multitask and manage priorities.
Attention to detail and data accuracy.
Required Skills
Change Management
Customer Relationship Management (CRM)
Vendor Management
Team Leadership / People Management
Analytical and logical thinking
Documentation and reporting
Preferred Qualifications
Clinical or healthcare system background (advantageous).
Basic knowledge of SQL programming.
Work Environment
Office-based role.
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