Safety Systems Associate II, PSS
Location: Bangalore
Employment Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: 261659
Job Summary
The Safety Systems Associate II (PSS) is responsible for supporting pharmacovigilance (PV) safety systems, including system configuration, maintenance, implementation, data migration, reporting, user support, and system validation activities. The role combines technical expertise with pharmacovigilance knowledge to ensure the effective operation of drug safety systems used for adverse event management and regulatory reporting.
The position supports both internal teams and external clients by maintaining validated safety systems, resolving technical issues, managing data migrations, and ensuring compliance with pharmacovigilance regulations and quality standards.
Key Responsibilities
Safety System Configuration & Administration
Configure and maintain pharmacovigilance safety systems based on project and client requirements.
Implement project-specific system configurations and updates.
Maintain detailed documentation for:
System Configurations
Requirement Changes
Validation Activities
System Updates
Ensure systems remain compliant with internal SOPs and regulatory requirements.
Pharmacovigilance System Support
Provide day-to-day support for drug safety systems.
Support internal users and external sponsors with system-related queries.
Troubleshoot and resolve technical and functional issues.
Monitor support mailboxes and respond to user requests in a timely manner.
Escalate complex issues to senior team members or vendors when required.
Participate in ticket management and issue tracking activities.
Data Extraction & Reporting
Generate routine and ad hoc safety reports from pharmacovigilance systems.
Perform data extractions for regulatory and safety reporting activities, including:
PSURs (Periodic Safety Update Reports)
DSURs (Development Safety Update Reports)
Six-Monthly Listings
Regulatory Safety Listings
Custom Client Reports
Ensure accuracy and completeness of extracted data.
Data Migration & System Implementation
Participate in safety database migration projects.
Support:
Data Mapping
Data Validation
Migration Testing
Migration Documentation
Assist with implementation and deployment of new safety systems and enhancements.
Ensure data integrity throughout migration and implementation processes.
User Acceptance Testing (UAT)
Execute User Acceptance Testing activities for:
New System Releases
Configuration Changes
Enhancements
Validation Projects
Prepare and maintain UAT documentation.
Identify defects and coordinate resolution activities.
Verify system functionality against business requirements.
Training & Change Management
Support change management activities during system upgrades and implementations.
Develop and deliver training on:
Technical System Features
Functional Workflows
Best Practices
Train team members and end users on safety system functionality.
Compliance & Quality Management
Ensure work is completed according to:
Pharmacovigilance Regulations
Internal SOPs
Validation Requirements
Quality Standards
Maintain awareness of current PV regulations and industry practices.
Support inspection and audit readiness activities.
Additional Responsibilities
Respond to mailbox queries and user support requests.
Monitor system failures and coordinate timely resolution.
Provide peer support and collaborate across project teams.
Perform additional tasks assigned by management.
Required Qualifications
Educational Requirements
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Computer Science
Information Technology
Software Engineering
Related Scientific or Technical Discipline
Equivalent relevant experience may be considered in lieu of educational qualifications.
Required Experience
Experience Level
Minimum 2 years of experience in:
Pharmacovigilance Systems
Drug Safety Systems
Clinical Systems Support
Safety Database Administration
System Operations Support
System Experience
Hands-on experience with one or more safety systems such as:
Argus Safety
ARISg
Veeva Vault Safety
Other Drug Safety Platforms
Additional Experience
Experience working with:
Validated Computer Systems
Document Management Systems
Regulatory Systems
Clinical or Safety Databases
Required Skills & Competencies
Pharmacovigilance Knowledge
Understanding of:
Drug Safety Operations
Adverse Event Reporting
Pharmacovigilance Workflows
Safety Data Management
Knowledge of:
Regulatory Reporting Requirements
Safety Database Operations
PV Compliance Standards
Technical Skills
Safety Database Configuration
Data Migration and Validation
System Integration Knowledge
User Acceptance Testing (UAT)
Report Generation and Data Extraction
Ticket and Incident Management
System Troubleshooting
Software Skills
Microsoft Office Suite:
Excel
Word
PowerPoint
Outlook
Working knowledge of:
Windows Environment
Database Applications
Document Management Systems
Preferred Qualifications
Life Science or IT/Computing Degree.
Clinical Research or Clinical Systems background.
Experience working with validated clinical or pharmacovigilance systems.
Knowledge of system integration methodologies.
Experience supporting global pharmacovigilance operations.
Key Competencies
Attention to Detail
Analytical Thinking
Problem Solving
Technical Troubleshooting
Data Accuracy & Integrity
Customer Service Orientation
Team Collaboration
Time Management
Communication Skills
Process Compliance
Work Environment
Office-based environment.
Collaboration with:
Pharmacovigilance Teams
Safety Operations Teams
Clinical Teams
IT & Systems Teams
External Sponsors and Clients
Exposure to global drug safety and regulatory environments.
Suitable Backgrounds
This role is ideal for professionals currently working as:
Safety Systems Associate
Argus Administrator
Pharmacovigilance Systems Analyst
Drug Safety Systems Specialist
Clinical Systems Associate
PV Technology Associate
Validation Associate
Safety Database Administrator
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