Safety Systems Specialist

Roles & Responsibilities
• Assist with overall safety trackers, applications, and tools implementation, support, configuration, and migration activities
• Provide service to clients either as a support function to client project groups or as a standalone business
• Ensure delivery of high-quality service to internal and external clients in a safe and cost-effective manner
• Conduct project-specific configurations in safety applications/tools
• Maintain and document trackers/applications/tools configuration based on requirements and updates
• Evaluate proposed project ideas or software changes through technical impact analysis and estimated business value
• Develop and document standard and ad hoc reports from safety trackers/applications/tools
• Support and educate end users and sponsors as needed
• Collaborate with training teams to develop safety application/tool-specific training modules
• Document user requirements and ensure timely delivery in collaboration with technical partners
• Provide guidance on use of standard safety trackers/tools, including advanced conditions and Standard MedDRA Queries (SMQ)
• Conduct routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings)
• Participate in data migration activities and related documentation
• Support change management and user training for trackers/tools
• Manage ticketing, issue resolution, and escalate issues as needed
• Respond to mailbox queries and provide vendor management support
• Train team members on technical and functional aspects of safety tools
• Update departmental SOPs, working practices, and guidelines
• Monitor tracker/tool failures and resolve issues promptly
• Perform user acceptance testing and complete required documentation
• Lead critical team projects and manage team workload

Qualification
• Degree in Life Sciences, IT, or Computing (relevant equivalent experience may be considered)

Experience
• Minimum 2 years in safety trackers/applications/tools operations support
• Experience with validated document management systems and drug safety trackers (e.g., intake/SAE/ESR trackers, SharePoint, in-house tools)
• Clinical background with clinical systems is preferred

Skills
• Strong technical and functional knowledge of PV systems
• Good understanding of SQL and ticket support applications
• Proficiency in Microsoft Office tools
• Strong attention to detail and ability to handle multiple priorities
• Good written and verbal communication skills
• Ability to work collaboratively and provide peer support

About the Company
Fortrea is a global leader in clinical research and pharmacovigilance services, providing innovative solutions for drug safety, clinical trial operations, and regulatory compliance. With a presence in India and worldwide, Fortrea offers professionals exposure to advanced clinical technologies, validated systems, and global trial operations while fostering a collaborative and high-quality service-driven work culture.