Company: Fortrea
Fortrea Official Website
Location: Bangalore (Hybrid)
Employment Type: Full-time
Requisition ID: 261413
1. Role Overview
The Safety Systems Specialist supports pharmacovigilance (PV) and drug safety technology systems through configuration, maintenance, migration, reporting, and user support activities.
The role combines technical systems expertise with pharmacovigilance operations knowledge to ensure efficient and compliant safety system management for internal and external clients.
2. Core Responsibilities
A. Safety System Configuration & Support
Configure and maintain pharmacovigilance (PV) safety systems
Document system configurations and changes
Support implementation and migration activities for safety platforms
Ensure systems operate according to validated processes and SOPs
B. Data Extraction & Reporting
Generate standard and ad hoc safety reports including:
PSURs (Periodic Safety Update Reports)
DSURs (Development Safety Update Reports)
6-monthly safety listings
Conduct routine and ad hoc data extractions from safety databases
Support reporting accuracy and data integrity
C. Data Migration & Validation
Participate in safety data migration activities
Prepare migration-related documentation
Perform User Acceptance Testing (UAT) and validation support
Ensure successful implementation of system updates and integrations
D. User Support & Issue Resolution
Support end users and sponsors on safety system usage
Monitor support mailboxes and resolve system-related issues
Manage tickets and escalate unresolved technical problems
Provide technical and functional training to team members
E. Compliance & Quality Management
Ensure compliance with:
Pharmacovigilance regulations
SOPs and validation requirements
Health & Safety standards
Maintain high-quality standards across all deliverables
Keep updated on evolving PV regulatory requirements
F. Change Management & Training
Support system-related change management activities
Assist in rollout and adoption of new system features
Train users on safety systems and workflows
3. Required Qualifications
Education
Degree in:
Life Sciences
IT / Computing
Equivalent relevant experience may be considered
Experience
Experience in systems operations support
Minimum 2+ years working with drug safety systems such as:
Oracle Argus Safety
ARISg
Veeva Vault
Experience with validated document management systems preferred
Technical Knowledge
Pharmacovigilance systems and workflows
System integration concepts
SQL basics (preferred)
Microsoft Office tools
Ticketing/support systems
4. Core Skills
Pharmacovigilance & Safety Skills
Safety systems configuration
PV reporting and listings
Data migration and validation
Regulatory compliance awareness
Technical & Systems Skills
User Acceptance Testing (UAT)
System support and troubleshooting
Data extraction and reporting
SQL and systems integration knowledge
Operational Skills
Ticket management
Documentation and SOP compliance
Multi-tasking and prioritization
Change management support
Behavioral Skills
Attention to detail
Strong communication skills
Team collaboration
Problem-solving mindset
Ability to work independently and under deadlines
5. Key Skill Areas
Pharmacovigilance (PV) Systems
Drug Safety Technology Platforms
Argus / ARISg / Veeva Systems
Data Migration & Validation
Safety Reporting (PSUR/DSUR)
System Support & User Training
6. Organizational Context
This role sits within Safety Systems / Pharmacovigilance Operations in a CRO environment and supports the technical backbone of drug safety monitoring and reporting activities.
It bridges:
Pharmacovigilance operations
Clinical safety compliance
Technology and systems management
7. Relative Career Positioning
Compared to the other roles you shared:
More technical-system oriented than CRA or Medical Information roles
Less field-based than CRA II
Strong pathway into:
Pharmacovigilance Operations
Drug Safety Technology
Clinical Systems Management
PV Analytics & Compliance
8. Typical Career Progression
Safety Systems Specialist
→ Senior Safety Systems Analyst
→ PV Systems Lead
→ Drug Safety Operations Manager
→ Pharmacovigilance Technology Director
If you want, I can now:
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