Senior Safety Technology Analyst

<h3>Accountabilities:</h3><li>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.</li><li>Manage safety database handovers between clients and the organization, both at project initiation and completion, ensuring seamless transitions and continuity of pharmacovigilance operations.</li><li>Design, implement, and maintain complex integrations between safety technology platforms and other applications to improve operational efficiency and service delivery.</li><li>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.</li><li>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.</li><li>Develop, review, and maintain technical documentation, presentations, standard operating procedures (SOPs), and other controlled documents related to safety technology solutions.</li><li>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.</li><li>Provide technical guidance, training, mentoring, and work direction to team members involved in system administration, database support, and technology implementation.</li><li>Partner with pharmacovigilance intelligence and regulatory-focused teams to maintain system compliance and proactively address evolving industry requirements.</li><li>Identify opportunities to optimize safety technology platforms, improve workflows, and strengthen system performance through continuous improvement initiatives.</li><li>Evaluate emerging pharmacovigilance technologies, including artificial intelligence applications, to support innovation and enhance operational capabilities.</li><h2>Requirements:</h2><li>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.</li><li>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.</li><li>Advanced knowledge and practical experience applying computer system regulations and industry guidance, including<strong>21 CFR Part 11, EMA Annex 11, and GAMP</strong>.</li><li>Demonstrated proficiency in SQL or other relevant scripting languages, along with experience using industry-standard service desk and incident management tools.</li><li>Strong understanding of pharmacovigilance processes, Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and applicable safety reporting standards.</li><li>Proven experience in system administration, complex configuration, application support, and integration of safety technology platforms.</li><li>Practical experience with system validation, change management, testing methodologies, and regulatory-compliant software implementation.</li><li>Excellent technical writing skills, with the ability to develop clear, accurate documentation and communicate complex technical concepts to diverse audiences.</li><li>Strong analytical and problem-solving abilities, supported by a client-focused approach and the capacity to manage complex technical challenges.</li><li>Excellent verbal and written communication skills, with the confidence to collaborate with stakeholders at different organizational levels and represent the safety technology function in cross-functional discussions.</li><li>Demonstrated leadership potential and the ability to coach, mentor, and guide team members while contributing to a collaborative working environment.</li><li>Familiarity with emerging pharmacovigilance technologies, including AI-enabled solutions, and a willingness to continuously develop technical knowledge.</li><li>A bachelor's degree in Engineering, Computer Science, or a related discipline is preferred; a master's degree is an advantage.</li><li>At least one year of experience in mentoring, training, or peer oversight is desirable.</li><li>Experience leading or contributing to system and process improvement initiatives, including at least one year of system validation design and execution, is preferred.</li><h2>Benefits:</h2><li>A flexible working environment designed to support productivity, professional development, and work-life balance.</li><li>Opportunities to contribute to global clinical research initiatives and technology solutions that support patient safety.</li><li>Professional growth opportunities across pharmacovigilance, clinical research technology, regulatory compliance, and system implementation.</li><li>Exposure to complex safety technology platforms, cross-functional projects, and emerging innovations, including AI-enabled solutions.</li><li>Opportunities to strengthen technical leadership skills through mentoring, training, and collaboration with experienced professionals.</li><li>A continuous learning environment that encourages knowledge sharing, adaptability, and technical excellence.</li><li>The opportunity to make a meaningful contribution to the development of therapies and the advancement of global healthcare.</li>