Senior Safety Technology Analyst

Overview

Senior Safety Technology Analyst to drive the strategic implementation and operational excellence of Parexel's pharmacovigilance safety technology systems, ensuring regulatory compliance, system optimization, and delivery of advanced safety solutions.

What you'll do

• 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 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, ensuring compliance with regulatory requirements, security standards, and quality protocols
• 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 authorship and review of standard operating procedures and controlled documents
• Lead issue resolution and collaboration with Parexel IT, vendors, Safety Services staff, and clients for analysis and closure of technical issues across supported systems
• Train, coach, and provide work direction to team members in system administration, database support, and strategic implementation activities
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure safety systems maintain regulatory compliance and meet evolving requirements

What you'll need

• Advanced technical expertise in pharmacovigilance safety technology systems, including complex configurations, system administration, and application support
• Exceptional interpersonal, verbal, and written communication skills with the ability to engage stakeholders at all levels
• Advanced analytical and problem-solving capabilities with a client-focused approach
• Strong leadership presence with the ability to mentor team members and represent the organization in cross-functional environments
• Demonstrated experience in system validation, change management, and regulatory compliance (21 CFR Part 11, EMA Annex 11, GAMP)
• Proficiency with standard scripting languages (SQL), Service Desk Tools, and project management methodologies
• Knowledge of emerging pharmacovigilance technologies, including AI, with a flexible attitude toward continuous learning
• Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP 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

Nice to have

• 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

Details

• Location: India, Hyderabad (remote)