Life Sciences Informatics Information Systems Specialist
This position will oversee the management and optimization of specialized information systems that support Life Sciences lifecycle services, with a specific emphasis on the Safety & Vigilance service area. Key responsibilities include ensuring adherence to safety regulations and fostering collaboration with cross-functional teams, IT, and business process owners in the safety and vigilance domain. The primary objective is to improve the efficiency and accuracy of both safety and vigilance information systems and regulatory operations information systems.
Responsibility:
- System Management and Optimization: Manage and optimize Life Sciences Informatics specialized information systems to ensure they meet operational needs and regulatory requirements.
- Compliance and Safety: Ensure all systems comply with relevant safety regulations and standards.
- Collaboration and Communication: Collaborate with crossfunctional teams, IT, and business process owners to enhance system efficiency and accuracy.
- Data Management: Oversee data integrity and ensure effective data management practices across safety and vigilance systems.
- Training and Support: Provide System Management and Optimization: Manage and optimize Life Sciences Informatics specialized information systems to ensure they meet operational needs and regulatory requirements.
- Troubleshooting: Collaborate with third-party solution providers to identify and resolve system issues promptly, ensuring minimal downtime and optimal system performance.
- Regulatory Operations: Support the integration and management of regulatory operations information systems.
- System Migration and Implementation: Contribute to system migration and implementation projects by providing technical expertise and ensuring smooth transitions. Thisincludes participating in project planning, testing, and validation to ensure that new systems meet business requirements and regulatory standards.
Education:
- Bachelor’s or Master’s Degree in Information Technology, Computer Science, Health Informatics, or a related field.
Experience:
- Minimum 3 Years: Experience in managing and optimizing information systems within the Life Sciences or a similar regulated industry.
- Experience with Safety & Vigilance Systems: Proven experience with Safety & Vigilance databases, including RxLogix
- Database Management: Proficiency in managing databases, particularly those related to Safety & Vigilance.
- Experience in safety data migration would be a plus.
- RxLogix Experience: Strong experience with RxLogix or similar safety and vigilance systems.
- Programming Skills: Familiarity with programming languages such as SQL or Python.
- Data Analysis Tools: Knowledge of data analysis tools and techniques.
- IT Infrastructure: Understanding of IT infrastructure and network systems.
- Regulatory Knowledge: Familiarity with relevant safety and vigilance regulations, including GxP framework.