Global clinical research environment dedicated to advancing patient safety and supporting the development of innovative therapies.
Position listed on behalf of a partner company based in India.
Responsibilities
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.
Collaborate with internal teams (IT, Quality Assurance, Total Quality Management) and external auditors to support 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.
Support change management activities in accordance with SDLC standards, including impact assessments, testing, system validation, and software updates.
Provide training, guidance, and peer support to new and developing team members.
Ensure systems and processes comply with pharmaceutical regulations, including 21 CFR Part 11, computer system validation requirements, and relevant quality standards.
Contribute to continuous improvement initiatives by identifying operational challenges and recommending technology enhancements.
Requirements
At least 2 years of experience with pharmacovigilance safety-supporting applications, including Argus, Vault Safety, EDC systems, Safety ERP platforms, and associated tools.
Minimum 2 years of experience collaborating with operational teams to investigate issues, gather requirements, and deliver technology solutions.
Demonstrated experience with computerized system validation methodologies in regulated environments.
Intermediate-level system administration and application support skills involving pharmacovigilance safety technology (safety databases, gateway and E2B reporting, report development, or signal detection tools).
Knowledge of computer system regulations and industry guidance, including 21 CFR Part 11, EMA Annex 11, and GAMP guidelines.
Intermediate understanding of pharmacovigilance processes, GVP, and GCP.
Working knowledge of SQL scripting and technical tools for system administration, data-related tasks, and troubleshooting.
Familiarity with SDLC processes, change management practices, and Agile methodologies.
Experience using industry-standard service desk tools.
Strong technical writing skills and ability to deliver presentations to stakeholders.
Fluency in English with excellent written and verbal communication skills.
Strong analytical and problem-solving abilities, attention to detail, and a client-focused approach.
Experience providing peer oversight, coaching, or training to colleagues.
Bachelor's degree in Engineering, Computer Science, or a related discipline preferred; master's degree an advantage.
Participation in system or process improvement initiatives is desirable.
Adaptable, proactive attitude with interest in emerging pharmacovigilance technologies, including AI.
Conditions
Flexible working environment designed to support productivity, professional growth, and work-life balance.
Opportunities to develop expertise in pharmacovigilance systems.