Safety Technology Analyst

• Conduct setup and support activities for Parexel safety databases and associated systems
• Configure new studies, generate periodic and ad-hoc reports, configure expedited report rules, and provide comprehensive end-user support
• Support safety database handovers from clients to Parexel and from Parexel to clients at study closeout
• Contribute to standard operating procedures and controlled documents for safety technology systems
• Support integration solutions between Parexel safety technologies and other applications
• Represent Safety Technology Management with cross-functional teams and external auditors
• Ensure adequate management of database systems, hardware, network security, quality standards, and project services
• Collaborate with IT, vendors, Safety Services staff, and clients to analyze, resolve, and close technical issues
• Support change management, impact assessments, testing, system validation, and software updates according to SDLC standards
• Provide training and mentoring to new or developing staff
• Ensure adherence to pharmaceutical regulations, including 21 CFR Part 11, computer system validation, and quality standards

• Intermediate system administration and application support skills in pharmacovigilance safety technology, including safety databases, gateway/E2B, report development, or signal detection
• Intermediate technical writing capability and experience with industry-standard Service Desk Tools
• Analytical and problem-solving skills with a client-focused approach and strong attention to detail
• Experience with software development lifecycle (SDLC) processes, change management, and Agile methodology
• Knowledge of 21 CFR Part 11, EMA Annex 11, and GAMP guidelines
• Intermediate knowledge of pharmacovigilance roles, standards, practices, GVP, and GCP
• Intermediate SQL scripting skills
• Interest in emerging pharmacovigilance safety technologies including AI
• Flexible attitude toward work assignments, new learning, and ability to manage multiple tasks
• 2+ years of experience in all functional areas of safety supportive applications, including Argus, Vault Safety, EDC, Safety ERP, secondary tools, and processes
• 2+ years of experience working closely with operational teams to manage issues, gather requirements, and deliver safety business process solutions
• Demonstrated experience with computerized system validation methodologies and processes
• Fluent in English with demonstrated ability to write technical documentation and deliver clear presentations to stakeholders
• Experience supporting team members through peer oversight, coaching, and training
• BA/BSc in Engineering or Computer Science is preferred; master's degree or equivalent is preferred
• Demonstrable participation in system or process improvement initiatives
• Experience working with cross-functional teams as a safety technology representative

• Flexible work arrangements
• Growth and continuous learning opportunities
• Training and mentoring opportunities
• Opportunity to work with emerging pharmacovigilance technologies
• Contributions to clinical research and safety technology innovation