Safety Systems Specialist Jobs Pharmacovigilance Systems at Fortrea in Bangalore for and regulatory reporting roles.
Company Overview
Fortrea is a global clinical research organization supporting pharmaceutical, biotechnology, and medical device companies across the full drug development lifecycle. With deep expertise in pharmacovigilance, clinical operations, and regulatory compliance, Fortrea delivers technology-enabled solutions that help ensure patient safety and regulatory readiness. The organization offers a collaborative, quality-driven environment where professionals contribute to global safety programs while building long-term careers. Safety Systems Specialist Jobs
Job Location & Employment Type
- Job Location: Bangalore, Karnataka
- Work Mode: Hybrid (Office + Remote)
- Employment Type: Full-Time
- Functional Area: Pharmacovigilance / Safety Systems
- Work Environment: Office-based with hybrid flexibility
Open Positions / Department Details
- Position Title: Safety Systems Specialist
- Department: Safety Systems / Pharmacovigilance Operations
- Job Requisition ID: 26130
This role supports safety system operations, configuration, reporting, and migration activities for both internal and external pharmacovigilance clients. Safety Systems Specialist Jobs
Key Roles & Responsibilities
The Safety Systems Specialist will act as a subject matter expert for safety trackers, applications, and tools, ensuring reliable system performance, regulatory compliance, and high-quality service delivery. Safety Systems Specialist Jobs
- Provide operational support for safety trackers, applications, and tools used in pharmacovigilance activities.
- Configure safety systems based on project requirements and document all configurations and subsequent changes.
- Support implementation, enhancement, and migration of safety trackers and applications across projects.
- Perform technical impact assessments for proposed system changes and contribute to business decision-making.
- Develop, generate, and document routine and ad-hoc reports from safety systems.
- Conduct data extractions to support regulatory deliverables such as PSURs, DSURs, and periodic safety listings.
- Actively participate in data migration planning, execution, and validation activities, including documentation.
- Support user acceptance testing (UAT) and ensure completion of required validation records.
- Provide guidance on advanced reporting features, including Standard MedDRA Queries (SMQs).
- Monitor system mailboxes and dashboards to identify and resolve tracker or application failures promptly.
- Manage ticketing activities, issue resolution, escalation, and follow-up with internal teams or vendors.
- Respond to system-related queries from users, sponsors, and stakeholders in a timely manner.
- Collaborate with training teams to develop and deliver system-specific training materials.
- Train team members on functional and technical aspects of safety trackers and applications.
- Support change management activities related to safety systems updates or enhancements.
- Maintain compliance with SOPs, working practices, and global pharmacovigilance regulations.
- Contribute to the creation and revision of departmental SOPs, guidelines, and working instructions.
- Lead or support critical team initiatives and manage workload distribution when required.
- Identify opportunities to improve system efficiency, data quality, and regulatory compliance.
- Perform additional responsibilities as assigned to support departmental and business objectives.
Eligibility Criteria
Education
- Degree in Life Sciences, Information Technology, Computer Science, or a related discipline.
- Relevant equivalent experience may be considered in place of formal education.
Experience
- Minimum 2+ years of experience in safety systems, drug safety trackers, or pharmacovigilance tools support.
- Hands-on experience with safety intake, SAE, ESR trackers, or similar PV systems (including SharePoint or in-house tools).
- Prior experience working with validated document management systems is required.
Safety Systems Specialist Jobs
Skills Required
Technical & Functional Skills:
- Strong knowledge of pharmacovigilance safety systems and trackers.
- Experience in safety system configuration, reporting, and data extraction.
- Understanding of safety system integrations and migration activities.
- Proficiency in Microsoft Office tools and Windows environments.
- Familiarity with ticket management systems and issue resolution workflows.
- Working knowledge of SQL is an added advantage.
Professional & Analytical Skills:
- High attention to detail with strong data review and documentation skills.
- Ability to manage multiple tasks, prioritize workload, and meet deadlines.
- Strong written and verbal communication skills.
- Logical thinking with the ability to review numerical and system-generated data.
- Team-oriented mindset with willingness to support peers and stakeholders.
Safety Systems Specialist Jobs
Preferred Qualifications
- Clinical background with exposure to clinical or safety systems.
- Experience supporting vendors or managing external system partners.
- Prior involvement in regulated PV environments with audit or inspection exposure.
Safety Systems Specialist Jobs
Salary & Benefits
- Compensation: As per company norms
- Benefits include hybrid working flexibility, professional training, exposure to global PV programs, and structured career development.
Selection Process
- Application screening
- Technical interview(s)
- HR discussion
Final selection will depend on technical expertise, compliance knowledge, and role suitability. Safety Systems Specialist Jobs
How to Apply
- Candidates must apply through official company career portals or authorised job listings only.
- IndiaPharmaJobs.in does not collect applications on behalf of employers.
Important Dates
- Job Posted: 2 days ago
- Application Deadline: 08 February 2026
Candidates are advised to apply early.
Why Apply for This Pharma Job?
This role offers an excellent opportunity to work in pharmacovigilance systems within a global clinical research environment. Professionals gain exposure to safety system configuration, regulatory reporting, and data migration while contributing directly to patient safety and compliance. The hybrid work model, global project exposure, and structured learning make this role ideal for safety systems specialists seeking long-term growth. Safety Systems Specialist Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical and clinical research job information platform. We are not affiliated with Fortrea or any of its group companies. Job information is shared for informational purposes only. Candidates should verify all details through official company sources before applying. Safety Systems Specialist Jobs
Final Call-to-Action
Experienced pharmacovigilance and safety systems professionals are encouraged to apply and strengthen their careers in global drug safety operations. Safety Systems Specialist Jobs
