This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Safety Technology Analyst based in India.
Join a global clinical research environment dedicated to advancing patient safety and supporting the development of innovative therapies. In this role, you will contribute to the management, configuration, and support of pharmacovigilance safety databases and related technology systems. You will work closely with Safety Services, IT, Quality Assurance, and external clients to ensure systems operate reliably and comply with industry regulations. Your responsibilities will span study setup, database handovers, technical troubleshooting, system validation, and continuous process improvement. You will also help strengthen operational efficiency through system integrations, accurate documentation, and effective change management. This opportunity is ideal for a technically minded professional who enjoys solving problems, collaborating across teams, and applying technology to support high-quality clinical research and patient safety.
- Configure, maintain, and support pharmacovigilance safety databases and associated applications, including new study setups, periodic and ad hoc report generation, expedited reporting rules, and end-user support.
- Support the planning and execution of safety database handovers when pharmacovigilance operations transition from clients to the organization or return to clients at study closeout.
- Develop, maintain, and update standard operating procedures (SOPs), technical documentation, and controlled documents related to safety technology systems.
- Contribute to the design, implementation, and maintenance of integrations between safety technology platforms and other applications to improve operational efficiency and service delivery.
- Collaborate with internal teams, including IT, Quality Assurance, and Total Quality Management, as well as external auditors, to support appropriate database administration, infrastructure security, network controls, quality standards, and project requirements.
- Work with IT specialists, software vendors, Safety Services teams, and clients to investigate, troubleshoot, document, and resolve technical issues affecting supported systems.
- Support change management activities in accordance with Software Development Life Cycle (SDLC) standards, including impact assessments, testing, system validation, and software updates.
- Provide training, guidance, and peer support to new and developing team members on safety technology platforms, system administration, and support procedures.
- Ensure that supported systems and processes comply with applicable pharmaceutical regulations, including 21 CFR Part 11, computer system validation requirements, and relevant quality standards.
- Contribute to continuous improvement initiatives by identifying operational challenges, recommending technology enhancements, and helping implement effective solutions.
- Maintain effective communication with cross-functional stakeholders to ensure technical requirements, project expectations, and operational priorities are understood and addressed.
Requirements:
- At least two years of experience working with pharmacovigilance safety-supporting applications across relevant functional areas, including Argus, Vault Safety, Electronic Data Capture (EDC) systems, Safety ERP platforms, and associated tools.
- A minimum of two years of experience collaborating with operational teams to investigate issues, gather requirements, and deliver technology solutions that support safety business processes.
- Demonstrated experience with computerized system validation methodologies and processes in regulated environments.
- Intermediate-level system administration and application support skills involving pharmacovigilance safety technology, such as safety databases, gateway and E2B reporting, report development, or signal detection tools.
- Knowledge of applicable computer system regulations and industry guidance, including 21 CFR Part 11, EMA Annex 11, and GAMP guidelines.
- Intermediate understanding of pharmacovigilance processes, industry standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP).
- Working knowledge of SQL scripting and the ability to use technical tools to support system administration, data-related tasks, and troubleshooting.
- Familiarity with Software Development Life Cycle processes, change management practices, and Agile methodologies.
- Experience using industry-standard service desk tools to record, track, investigate, and resolve technical issues.
- Strong technical writing skills, with the ability to prepare clear documentation and deliver effective presentations to stakeholders.
- Fluency in English, with excellent written and verbal communication skills and the ability to collaborate effectively across multidisciplinary and geographically distributed teams.
- Strong analytical and problem-solving abilities, attention to detail, and a client-focused approach to technical support.
- Experience providing peer oversight, coaching, or training to colleagues, with a willingness to support team development and knowledge sharing.
- A bachelor's degree in Engineering, Computer Science, or a related discipline is preferred; a master's degree or equivalent qualification is an advantage.
- Participation in system or process improvement initiatives is desirable, as is experience representing a safety technology function in cross-functional teams.
- An adaptable, proactive attitude, with an interest in emerging pharmacovigilance technologies, including artificial intelligence, and a commitment to continuous learning.
Benefits:
- A flexible working environment designed to support productivity, professional growth, and work-life balance.
- Opportunities to develop expertise in pharmacovigilance systems, clinical research technology, and regulatory compliance.
- Exposure to global clinical research projects and collaboration with multidisciplinary teams.
- Opportunities to contribute to system implementation, validation, integration, and process improvement initiatives.
- Ongoing learning and professional development in emerging safety technologies, including AI-enabled solutions.
- Opportunities to build technical leadership skills through peer mentoring, training, and knowledge sharing.
- A collaborative environment that encourages innovation, adaptability, and continuous improvement.
- The opportunity to contribute to clinical research operations that support patient safety and the development of new therapies.
