Safety Technology Analyst

About The Role

We are seeking a Safety Technology Analyst (STA) to join our Hyderabad-based team. As a Safety Technology Analyst, you will support critical pharmacovigilance operations and safety database management that advance patient safety and regulatory compliance in India.

• Conduct setup and support activities for Parexel safety databases and associated systems, including new study configuration, periodic and ad-hoc report generation, expedited report rule configuration, and comprehensive end-user support
• Support the planning and delivery of safety database handovers from client to Parexel when taking over pharmacovigilance operations, and from Parexel to client at study closeout
• Contribute to the development and maintenance of standard operating procedures and controlled documents related to safety technology systems in Telangana
• Support the delivery of integration solutions between Parexel safety technologies and other applications to enhance operational efficiency and service capabilities for our Indian operations
• Represent Safety Technology Management with cross-functional Parexel teams (TQM, QA, IT) and external auditors to ensure adequate management of database systems, hardware, network security, quality standards, and project services
• Collaborate with Parexel IT, vendors, Safety Services staff, and clients to analyze, resolve, and close technical issues for supported systems within the Hyderabad / Secunderabad region
• Support change management activities including impact assessments, testing methodologies, system validation, and software updates in accordance with Software Development Life Cycle standards
• Provide training and mentoring to new or developing staff on safety technology systems and support activities
• Ensure adherence to pharmaceutical regulations including 21 CFR Part 11 compliance, computer system validation, and quality standards relevant to the Indian market