Safety Systems Associate II (PSS)
Company
Fortrea – A global clinical research organization providing pharmacovigilance, clinical development, and safety system solutions to support drug safety and regulatory compliance.
Job Details
Job Title: Safety Systems Associate II (PSS)
Job Requisition ID: 261659
Employment Type: Full-time
Location: Bangalore, India
Work Environment: Office or Remote
Application Deadline: June 30, 2026
About the Role
The Safety Systems Associate II supports the implementation, configuration, migration, and maintenance of pharmacovigilance (PV) safety systems.
This role ensures reliable system performance, regulatory compliance, and high-quality data management across safety databases used in clinical and post-marketing environments.
You will act as a key technical and functional support member within the PV systems team, collaborating with internal teams and external clients.
Key Responsibilities
1. Safety Systems Support & Configuration
Support implementation, configuration, and migration of safety systems.
Perform project-specific system configuration activities.
Maintain and document system configurations and updates.
2. Reporting & Data Extraction
Develop standard and ad-hoc safety system reports.
Perform data extraction for:
PSURs
DSURs
Periodic listings (e.g., 6-month reports)
3. System Operations & Issue Management
Monitor system mailboxes for failures or issues.
Manage ticket resolution and escalate system problems when required.
Support end users and sponsors with system queries.
4. Data Migration & Validation
Participate in data migration activities.
Support documentation and validation of migrated data.
Perform User Acceptance Testing (UAT) and document results.
5. Training & Change Management
Support system training for users and team members.
Assist in change management activities related to system updates.
Provide technical and functional guidance to stakeholders.
6. Compliance & Quality Assurance
Ensure adherence to:
SOPs
Pharmacovigilance (PV) regulations
Maintain high-quality standards in all deliverables.
7. Collaboration & Team Support
Work closely with cross-functional PV and IT teams.
Provide peer support and assist in resolving technical issues.
Respond to system-related mailbox queries.
Required Qualifications
Education
Degree in:
Life Sciences, or
IT / Computer Science
Equivalent relevant experience may be considered.
Experience
Minimum 2+ years of experience in:
Safety systems or PV systems support
Systems operations in clinical/pharma environment
Experience with safety databases such as:
Argus
ARISg
Veeva Safety (or similar systems)
Experience with validated document management systems
Technical Skills
Strong knowledge of Microsoft Office tools.
Understanding of system integration concepts.
Familiarity with ticketing/support systems (preferred).
Basic knowledge of SQL (preferred).
Core Skills
Strong attention to detail.
Ability to manage multiple tasks and priorities.
Good analytical and logical thinking skills.
Strong written and verbal communication skills.
Good teamwork and collaboration abilities.
Ability to handle structured numerical and technical data accurately.
Preferred Qualifications
Clinical or pharmacovigilance systems experience.
Knowledge of SQL programming.
Experience in IT or clinical system support environments.
Exposure to regulated environments (GxP systems).
Work Environment
Office-based or remote work model.
Requires handling of system monitoring and support tasks.
Collaborative cross-functional environment.
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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