Global clinical research and healthcare technology environment dedicated to advancing patient safety and accelerating the development of new therapies.
Position listed on behalf of a partner company based in India.
Responsibilities
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 at project initiation and completion.
Design, implement, and maintain complex integrations between safety technology platforms and other applications.
Collaborate with IT, Quality Assurance, Safety Operations, and external auditors to ensure compliance with regulatory requirements, information security standards, and quality procedures.
Lead change management activities in accordance with SDLC principles, including impact assessments, testing strategies, system validation, software updates, and controlled implementation.
Develop, review, and maintain technical documentation, presentations, SOPs, and other controlled documents.
Oversee the investigation and resolution of technical issues by coordinating with internal IT teams, software vendors, Safety Services colleagues, and clients.
Provide technical guidance, training, mentoring, and work direction to team members.
Partner with pharmacovigilance intelligence and regulatory-focused teams to maintain system compliance.
Identify opportunities to optimize safety technology platforms and strengthen system performance.
Evaluate emerging pharmacovigilance technologies, including AI applications.
Requirements
At least 5 years of hands-on experience with pharmacovigilance safety-supporting applications, including Argus, Vault Safety, EDC systems, Safety ERP platforms, and related tools.
Minimum 5 years of experience working closely with Safety Operations teams to investigate technical issues, gather business requirements, and deliver 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, GVP, 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.
Strong analytical and problem-solving abilities with a client-focused approach.
Excellent verbal and written communication skills.
Demonstrated leadership potential and ability to coach, mentor, and guide team members.
Familiarity with emerging pharmacovigilance technologies, including AI-enabled solutions.
Bachelor's degree in Engineering, Computer Science, or a related discipline preferred; master's degree an advantage.
At least 1 year of experience in mentoring, training, or peer oversight is desirable.
Experience leading or contributing to system and process improvement initiatives, including at least 1 year of system validation design and execution, is preferred.
Conditions
Flexible working environment designed to support productivity, professional development, and work-life balance.
Opportunities to contribute to global clinical research.