Senior Safety Technology Analyst in भारत

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Safety Technology Analyst based in India. Join a global clinical research and healthcare technology environment dedicated to advancing patient safety and accelerating the development of new therapies. In this role, you will lead the implementation, configuration, and optimization of pharmacovigilance safety systems that support critical drug safety operations. You will collaborate with Safety Operations, IT, Quality Assurance, clients, and external auditors to ensure technology solutions meet stringent regulatory and quality standards. Your expertise will help streamline system integrations, strengthen compliance, and improve the reliability of safety data management. You will also drive system validation, change management, and continuous improvement initiatives while mentoring colleagues and sharing technical knowledge. This is an opportunity to combine deep technical expertise, regulatory knowledge, and cross-functional leadership in a collaborative, innovation-driven environment where your work contributes to protecting patients worldwide. Accountabilities: - Lead the configuration, implementation, administration, and ongoing support of pharmacovigilance safety databases and associated applications, including new study setups, periodic and ad hoc reporting, expedited reporting rule configuration, and end-user support. - Manage safety database handovers between clients and the organization, both at project initiation and completion, ensuring seamless transitions and continuity of pharmacovigilance operations. - Design, implement, and maintain complex integrations between safety technology platforms and other applications to improve operational efficiency and service delivery.

- Collaborate with IT, Quality Assurance, Safety Operations, and external auditors to ensure safety systems comply with applicable regulatory requirements, information security standards, and quality procedures. - Lead change management activities in accordance with Software Development Life Cycle (SDLC) principles, including impact assessments, testing strategies, system validation, software updates, and controlled implementation. - Develop, review, and maintain technical documentation, presentations, standard operating procedures (SOPs), and other controlled documents related to safety technology solutions. - Oversee the investigation and resolution of technical issues by coordinating with internal IT teams, software vendors, Safety Services colleagues, and clients to ensure appropriate analysis, escalation, and closure. - Provide technical guidance, training, mentoring, and work direction to team members involved in system administration, database support, and technology implementation. - Partner with pharmacovigilance intelligence and regulatory-focused teams to maintain system compliance and proactively address evolving industry requirements. - Identify opportunities to optimize safety technology platforms, improve workflows, and strengthen system performance through continuous improvement initiatives. - Evaluate emerging pharmacovigilance technologies, including artificial intelligence applications, to support innovation and enhance operational capabilities. Requirements: - At least five years of hands-on experience with pharmacovigilance safety-supporting applications, including Argus, Vault Safety, Electronic Data Capture (EDC) systems, Safety ERP platforms, and related tools across multiple functional areas. - A minimum of five years of experience working closely with Safety Operations teams to investigate technical issues, gather business requirements, and deliver effective technology solutions. - Advanced knowledge and practical experience applying computer system regulations and industry guidance, including 21 CFR Part 11, EMA Annex 11, and GAMP .