Safety Systems Specialist
Company
Fortrea – A global clinical research organization specializing in pharmacovigilance, clinical safety systems, and regulatory technology support for drug safety operations.
Job Details
Job Title: Safety Systems Specialist
Job Requisition ID: 261413
Employment Type: Full-time
Location: Bangalore, India
Work Model: Hybrid
Application Deadline: June 30, 2026
About the Role
The Safety Systems Specialist supports the implementation, configuration, migration, and maintenance of pharmacovigilance (PV) safety systems.
This role ensures smooth operation of validated safety databases and supports regulatory compliance, system reporting, and user support across clinical and post-marketing safety activities.
Key Responsibilities
1. Safety System Configuration & Support
Configure safety systems based on project requirements.
Maintain system configuration and update documentation.
Support system implementation and ongoing maintenance activities.
2. Reporting & Data Extraction
Develop standard and ad-hoc safety reports.
Perform data extraction for:
PSURs
DSURs
Periodic safety listings (e.g., 6-month reports)
3. System Operations & Issue Resolution
Manage ticketing systems and resolve technical issues.
Monitor system mailboxes for failures and alerts.
Escalate system issues when required.
4. Data Migration & Validation
Participate in data migration projects.
Document migration processes and validation activities.
Perform User Acceptance Testing (UAT) and ensure compliance.
5. Training & User Support
Support and train end users and stakeholders.
Assist with change management activities.
Respond to system-related queries from users.
6. Compliance & Quality Assurance
Ensure adherence to:
SOPs
Pharmacovigilance regulations
Global safety reporting standards
Maintain high-quality documentation and system accuracy.
7. Collaboration & Team Support
Work closely with PV systems and IT teams.
Provide peer support and technical guidance.
Contribute to continuous process improvement initiatives.
Required Qualifications
Education
Degree in:
Life Sciences, or
IT / Computer Science
Equivalent experience may be considered.
Experience
Minimum 2+ years in:
Drug safety systems or PV systems support
Systems operations in clinical/pharma environments
Experience with systems such as:
Argus
ARISg
Veeva Safety (or similar)
Technical Skills
Strong knowledge of Microsoft Office tools.
Understanding of system integration concepts.
Basic SQL knowledge (preferred).
Experience with ticketing/support tools (preferred).
Core Skills
Strong attention to detail and accuracy.
Ability to manage multiple priorities.
Good analytical and problem-solving skills.
Strong written and verbal communication skills.
Ability to work independently and in teams.
Preferred Qualifications
Background in clinical or pharmacovigilance systems.
Experience in SQL or database querying.
Exposure to validated systems and regulated environments.
Work Environment
Hybrid work model (office + remote).
Pharmacovigilance systems and clinical safety operations environment.
May involve system monitoring and support activities.
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and fostering an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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