[Hiring] Senior Safety Technology Analyst @Parexel

Role Description

We are seeking a Senior Safety Technology Analyst to join our team. As a Senior Safety Technology Analyst, you will drive the strategic implementation and operational excellence of Parexel's pharmacovigilance safety technology systems. This position plays a critical role in ensuring regulatory compliance, system optimization, and the delivery of advanced safety solutions that protect patient safety and accelerate clinical research.

You'll collaborate with cross-functional teams across Safety Operations, IT, Quality Assurance, and external auditors, following industry-standard processes and regulatory frameworks. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing patient safety, driving operational excellence, and shaping the future of clinical research technology.

Key Responsibilities

• 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, ensuring seamless transitions for complex pharmacovigilance operations.
• Design and deliver complex integration solutions between Parexel safety technologies and other applications to enhance operational capabilities and drive service excellence.
• 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 proper analysis and closure of technical issues across supported systems.
• Train, coach, and provide work directions 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 proactively meet evolving requirements.

Qualifications

• 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 and new challenges.
• Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements.

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.

Preferred Qualifications

• 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

• Flexibility, growth, and creating space for people to do their best work.
• Opportunities to explore career paths and expand skills across clinical research technology, regulatory compliance, and strategic system implementation.