Safety Systems Associate II, PSS
Company: Fortrea
Job Title: Safety Systems Associate II, PSS
Job ID: 261659
Location: Bengaluru, Karnataka
Job Category: Pharmacovigilance Systems / Clinical Safety Systems
Employment Type: Full-time
Job Summary
Fortrea is hiring a Safety Systems Associate II, PSS to support pharmacovigilance safety systems implementation, configuration, data migration, reporting, and end-user support. This role combines technical systems knowledge with drug safety domain expertise and focuses on validated safety platforms, system support, and operational issue management.
Key Responsibilities
Support implementation, configuration, and maintenance of drug safety systems.
Perform project-specific system configurations based on business requirements.
Maintain configuration documentation and change records.
Develop:
Standard reports
Ad-hoc safety reports
Regulatory listings
Support routine data extraction for:
PSURs
DSURs
6-month safety listings
Participate in data migration activities and migration documentation.
Support change management and system-related training.
Manage:
Support tickets
Issue troubleshooting
System escalations
Perform User Acceptance Testing (UAT) and required validation documentation.
Monitor system failure mailboxes and resolve issues promptly.
Support internal users and sponsors with technical/system queries.
Train team members on functional and technical workflows.
Ensure compliance with SOPs and current pharmacovigilance regulations.
Required Qualifications
Life Sciences Degree OR IT / Computing Degree
Experience in systems operations support
Experience with validated document management systems
Minimum 2+ years of experience with drug safety systems
Required safety systems experience:
Argus
ARISg
Veeva
Equivalent pharmacovigilance platforms
Required Experience
Minimum 2+ years experience
Experience in:
Pharmacovigilance safety systems
Systems support
Configuration management
Data migration
Ticket management
UAT / validation support
Required Skills
Technical Skills
Pharmacovigilance Systems
Drug Safety Systems
Argus Safety
ARISg
Veeva
System Configuration
Data Migration
Safety Reporting
PSUR / DSUR Listings
User Acceptance Testing (UAT)
Ticket Management
System Troubleshooting
System Integration
Microsoft Office
Validated Systems Support
Preferred Technical Skills
SQL
Clinical Systems Experience
Ticket Support Applications
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