Safety Systems Specialist
Company: Fortrea
Job Title: Safety Systems Specialist
Job ID: 261413
Location: Bengaluru, Karnataka
Job Category: Pharmacovigilance Systems / Clinical Safety Technology
Employment Type: Full-time
Work Mode: Office / Remote
Job Summary
Fortrea is hiring a Safety Systems Specialist to support pharmacovigilance safety systems implementation, configuration, migration, reporting, and technical support. This role combines technical system expertise with drug safety domain knowledge and focuses on maintaining validated safety platforms, resolving system issues, supporting users, and ensuring regulatory-compliant pharmacovigilance operations.
Key Responsibilities
Support implementation and maintenance of pharmacovigilance safety systems.
Configure project-specific settings in safety platforms based on client requirements.
Maintain system configuration documentation and change records.
Generate:
Standard reports
Ad-hoc reports
Regulatory safety listings
Perform routine and ad-hoc data extraction for:
PSURs
DSURs
6-month safety listings
Participate in data migration projects and related documentation.
Support:
Change management activities
End-user system training
Sponsor support
Manage support tickets, troubleshoot issues, and escalate technical problems when required.
Perform User Acceptance Testing (UAT) and validation documentation.
Monitor system failure mailboxes and resolve issues promptly.
Train team members on system functionality and workflows.
Respond to operational and technical support queries.
Ensure compliance with SOPs and current pharmacovigilance regulations.
Required Qualifications
Life Sciences Degree OR IT / Computing Degree
Experience in:
Systems operations support
Validated document management systems
Safety systems support
Good knowledge of:
Microsoft Office
System integration concepts
Required Experience
Minimum 2+ years of experience in drug safety systems
Required platform exposure:
Argus Safety
ARISg
Veeva
Equivalent pharmacovigilance systems
Experience in:
System configuration
Data migration
UAT / validation
Ticket management
Technical support
Required Skills
Technical Skills
Pharmacovigilance Systems
Drug Safety Systems
Argus Safety
ARISg
Veeva
Safety Reporting Systems
Data Migration
System Configuration
UAT Testing
Ticket / Incident Management
Technical Troubleshooting
System Integration
PSUR / DSUR Support
Microsoft Office
Preferred Technical Skills
SQL
Clinical Systems Experience
Ticket Support Applications
Validated Systems Documentation
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