Safety Systems Specialist II – PSS
Company: Fortrea
Job Location: Bangalore, India
Employment Type: Full-Time
Work Model: Office / Remote
Job Requisition ID: 261662
Application Deadline: September 30, 2026
Job Overview
The Safety Systems Specialist II will support the implementation, configuration, migration, maintenance, and operational support of pharmacovigilance (PV) safety systems.
The role requires a strong combination of business, pharmacovigilance, and technical knowledge to support internal and external clients, project teams, system implementation activities, and ongoing safety-system operations.
Key Responsibilities
Act as a PV Safety Systems Subject Matter Expert (SME) with strong business and technical knowledge.
Perform project-specific configuration and maintenance of safety systems.
Maintain accurate system configuration documentation and update it based on changing business requirements.
Perform technical impact assessments for proposed system/software changes.
Develop and maintain standard and ad-hoc safety system reports.
Support and educate end users, sponsors, and business stakeholders.
Collaborate with training teams to develop safety-system-specific training modules.
Understand business requirements, document user requirements, and coordinate delivery with technical partners.
Provide guidance on front-end safety system reporting, advanced conditions, and Standard MedDRA Queries (SMQs).
Perform routine and ad-hoc data extraction, including PSURs, DSURs, and periodic safety listings.
Participate in data migration activities, including migration documentation and validation.
Support change management, system implementation, and user training.
Manage support tickets, investigate issues, resolve system problems, and escalate where required.
Monitor and respond to system-support mailboxes and system-failure notifications.
Coordinate with and manage system vendors/technology partners.
Train team members on technical and functional aspects of safety systems.
Ensure compliance with relevant SOPs, working practices, guidelines, and current PV regulations.
Update departmental SOPs, working practices, and system-related guidelines when required.
Identify opportunities to improve compliance, quality, efficiency, and system processes.
Perform User Acceptance Testing (UAT) and complete associated documentation.
Lead critical team projects and support workload/resource management.
Perform other duties and responsibilities as assigned.
Minimum Qualifications
Bachelor’s degree in Life Sciences, IT, Computer Science, or a related field.
Relevant equivalent professional experience may be considered in lieu of educational requirements.
Strong teamwork and peer-support skills.
Ability to prioritize and manage multiple tasks simultaneously.
Strong attention to detail.
Good written and verbal communication skills.
Strong logical thinking and proofreading skills.
Ability to work with numerical and technical data accurately.
Good working knowledge of Microsoft Office and Windows.
Ability to operate standard office equipment.
Required Experience
Experience in Safety Systems / Systems Operations Support.
Experience working with validated document management systems.
Minimum 4+ years of experience with drug safety systems, such as:
Oracle Argus Safety
ARISg
Veeva Safety
Equivalent pharmacovigilance safety platforms
Good working knowledge of Microsoft Office tools.
Understanding of system integration and safety-system interfaces.
Preferred Skills
Clinical background with experience working on clinical systems.
Knowledge of SQL programming.
Experience with ticket management/support applications.
Experience in system configuration, validation, migration, UAT, and change management.
Knowledge of pharmacovigilance processes and regulatory requirements.
Core Skills Required
Pharmacovigilance (PV) | Argus Safety | ARISg | Veeva Safety | Safety System Configuration | System Support | System Migration | UAT | SQL | Data Extraction | SMQ | PSUR | DSUR | Ticket Management | Vendor Management | System Integration | Change Management | SOPs | Regulatory Compliance
Experience – 1-Line Summary
4+ years of experience in pharmacovigilance safety systems, preferably with hands-on expertise in Argus/ARISg/Veeva, system configuration, support, migration, UAT, reporting, data extraction, and system integration.
Salary Package – Market Estimate
Official salary is not disclosed in the JD. Based on current Bangalore market estimates for comparable Fortrea/Safety Systems roles and the 4+ year technical requirement, an expected package would be approximately ₹8–12 LPA CTC, depending on experience, Argus/Veeva expertise, SQL, configuration, and negotiation.
Likely range: ₹8–12 LPA
Strong/experienced candidate: ₹10–14 LPA may be achievable depending on specialized safety-system expertise.
Note: This is a market estimate, not an officially confirmed Fortrea salary range.
Work Environment
Office environment or remote, depending on business requirements.
Full-time position.
Role involves collaboration with internal teams, clients, business stakeholders, technology partners, and vendors.
Ideal Candidate Profile
A candidate with 4+ years of hands-on experience in PV Safety Systems, particularly Argus/ARISg/Veeva, combined with system configuration, support, migration, UAT, reporting, SQL, ticket management, and stakeholder coordination experience would be a strong fit for this position.
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