Senior Safety Technology Analyst

Job Description:

• Lead the setup, configuration, and support of Parexel's safety database and associated systems, including new study implementations, periodic and ad-hoc report generation, expedited report rule configuration, and comprehensive end-user support
• Direct the planning and execution of safety database handovers from clients to Parexel and from Parexel to clients at project completion
• Design and deliver complex integration solutions between Parexel safety technologies and other applications
• Represent Safety Technology Management in cross-functional collaboration with IT, Quality Assurance, and external auditors
• Lead change management initiatives aligned with Software Development Life Cycle principles, including impact assessments, testing methodologies, system validation, and software updates
• Develop and deliver presentations and technical documentation for safety technology solutions, including standard operating procedures and controlled documents
• Lead issue resolution and collaboration with Parexel IT, vendors, Safety Services staff, and clients
• Train, coach, and provide work directions to team members
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure safety systems maintain regulatory compliance

Requirements:

• 5+ years of hands-on experience with safety supportive applications (Argus, Vault Safety, EDC, Safety ERP) across all functional areas and secondary tools
• 5+ years of experience working closely with safety operations teams to manage issues, gather requirements, and deliver technology solutions
• Advanced knowledge and practical application of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP)
• Demonstrated proficiency with standard scripting languages (SQL) and industry-standard Service Desk Tools
• Strong technical writing capability and proven ability to communicate complex concepts clearly to diverse audiences
• Advanced technical expertise in pharmacovigilance safety technology systems, including complex configurations, system administration, and application support
• Advanced analytical and problem-solving capabilities with a client-focused approach
• Demonstrated experience in system validation, change management, and regulatory compliance
• Knowledge of emerging pharmacovigilance technologies, including AI
• Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements
• BA/BSc in Engineering, Computer Science, or related field; master's degree preferred
• 1+ years of direct mentorship, training, or peer oversight experience
• Demonstrated lead participation in system/process improvement initiatives and 1+ years of system validation design and execution

Benefits:

• Flexible work arrangements
• Growth opportunities
• Continuous learning opportunities