Safety Systems Specialist
Location: Bangalore
Job Type: Full-Time
Work Model: Hybrid
Application Deadline: April 30, 2026
Job Requisition ID: 26130
Job Overview
The Safety Systems Specialist will support the implementation, configuration, migration, and maintenance of safety trackers, pharmacovigilance applications, and drug safety systems. This role is responsible for delivering high-quality operational and technical support to internal and external stakeholders while ensuring cost-effective and compliant pharmacovigilance system management. The ideal candidate will play a key role in supporting project teams, optimizing safety system performance, and maintaining operational excellence across pharmacovigilance technology platforms.
Experience Required
Minimum 2 years of experience in drug safety trackers, applications, tools, or systems
Experience in safety systems or tracker operational support roles
Experience working with validated document management systems
Hands-on experience with intake, SAE, ESR, or other pharmacovigilance tracking tools
Working knowledge of Microsoft Office applications
Understanding of safety system integrations
Experience with ticket management or issue resolution systems preferred
Key Responsibilities
Support implementation, configuration, migration, and maintenance of safety systems, trackers, and applications
Configure project-specific safety tools based on business and technical requirements
Maintain and document safety system configurations, updates, and changes
Conduct technical impact analysis for software changes and proposed enhancements
Develop and generate standard and ad hoc safety reports
Support end users and sponsors with system-related guidance and troubleshooting
Collaborate with training teams to develop safety systems training modules
Gather business requirements and document user specifications in collaboration with stakeholders
Provide guidance on safety tracker reporting, advanced conditions, and Standard MedDRA Queries (SMQ)
Conduct routine and ad hoc data extractions including PSURs, DSURs, and six-monthly listings
Participate in data migration and migration-related documentation activities
Support change management initiatives and user training for system updates
Manage ticket resolution, escalate technical issues, and monitor issue logs
Respond to mailbox and support queries in a timely manner
Coordinate vendor management activities
Train team members on technical and functional system processes
Ensure compliance with SOPs and current pharmacovigilance regulations
Update departmental SOPs, working practices, and guidelines as needed
Monitor trackers and applications for failures and ensure timely resolution
Perform User Acceptance Testing (UAT) and maintain required documentation
Lead team projects and manage workload distribution effectively
Identify opportunities to improve compliance, quality, and operational efficiency
Required Qualifications
Bachelor’s degree in Life Sciences, IT, Computer Science, or related field
Equivalent relevant experience may be considered in place of formal education
Strong written and verbal communication skills
Excellent organizational and multitasking abilities
High attention to detail and accuracy
Strong analytical and logical thinking skills
Good keyboard and computer proficiency
Ability to manage priorities and multiple assignments effectively
Preferred Qualifications
Clinical background with experience in clinical systems
Knowledge of SQL programming language
Experience with ticket support/helpdesk applications
Work Environment
Hybrid office-based working environment
Why Join This Opportunity
This position offers a strong career path for professionals looking to build expertise in pharmacovigilance systems, drug safety operations, safety database management, and pharmacovigilance technology support within a dynamic and collaborative environment.
Apply now to advance your career in pharmacovigilance systems and safety technology.
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