Senior Safety Technology Analyst

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.
Demonstrated proficiency in SQL or other relevant scripting languages, along with experience using industry-standard service desk and incident management tools.
Strong understanding of pharmacovigilance processes, Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and applicable safety reporting standards.
Proven experience in system administration, complex configuration, application support, and integration of safety technology platforms.
Practical experience with system validation, change management, testing methodologies, and regulatory-compliant software implementation.
Excellent technical writing skills, with the ability to develop clear, accurate documentation and communicate complex technical concepts to diverse audiences.
Strong analytical and problem-solving abilities, supported by a client-focused approach and the capacity to manage complex technical challenges.
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.
Demonstrated leadership potential and the ability to coach, mentor, and guide team members while contributing to a collaborative working environment.
Familiarity with emerging pharmacovigilance technologies, including AI-enabled solutions, and a willingness to continuously develop technical knowledge.
A bachelor's degree in Engineering, Computer Science, or a related discipline is preferred; a master's degree is an advantage.
At least one year of experience in mentoring, training, or peer oversight is desirable.
Experience leading or contributing to system and process improvement initiatives, including at least one year of system validation design and execution, is preferred.
Benefits:
A flexible working environment designed to support productivity, professional development, and work-life balance.
Opportunities to contribute to global clinical research initiatives and technology solutions that support patient safety.
Professional growth opportunities across pharmacovigilance, clinical research technology, regulatory compliance, and system implementation.
Exposure to complex safety technology platforms, cross-functional projects, and emerging innovations, including AI-enabled solutions.
Opportunities to strengthen technical leadership skills through mentoring, training, and collaboration with experienced professionals.
A continuous learning environment that encourages knowledge sharing, adaptability, and technical excellence.
The opportunity to make a meaningful contribution to the development of therapies and the advancement of global healthcare.