Senior Safety Technology Analyst

Overview

The Senior Safety Technology Analyst will drive the strategic implementation and operational excellence of pharmacovigilance safety technology systems, supporting regulatory compliance, system optimization, and advanced safety solutions. The role collaborates with Safety Operations, IT, Quality Assurance, external auditors, vendors, clients, and the Global Pharmacovigilance Intelligence Office.

What you'll do

• Lead the setup, configuration, and support of safety databases 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 safety technologies and other applications.
• Represent Safety Technology Management in 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, including standard operating procedures and controlled documents.
• Lead issue resolution and collaborate with Parexel IT, vendors, Safety Services staff, and clients to analyze and close technical issues.
• Train, coach, and provide work directions to team members in system administration, database support, and strategic implementation activities.
• Collaborate with the Global Pharmacovigilance Intelligence Office to maintain regulatory compliance and proactively meet evolving requirements.

What you'll need

• 5+ years of hands-on experience with safety supportive applications, including 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 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, including 21 CFR Part 11, EMA Annex 11, and GAMP.
• Advanced knowledge and practical application of computer system regulations and guidance, including 21 CFR Part 11, EMA Annex 11, and GAMP.
• Proficiency with standard scripting languages, including SQL, Service Desk Tools, and project management methodologies.
• Demonstrated proficiency with standard scripting languages, including SQL, and industry-standard Service Desk Tools.
• 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.
• 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 a related field; master's degree preferred.
• 1+ years of direct mentorship, training, or peer oversight experience.
• Demonstrated lead participation in system/process improvement initiatives.
• 1+ years of system validation design and execution.

Details

• Location: Hyderabad, India.
• Work mode: Remote.