Regulatory Information Management Systems (RIMS) with Veeva Vault certification

- The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective business operations.

- The role is accountable for the quality and accuracy of information they need to handle on a daily basis.

- The role provides operational support to Regulatory Information Management Systems (RIMS) end-users and can be extended to broader profiles of Regulatory Data Management, inclusive of document management, submission management, RIM and software development life cycle.

Responsibilities of this role are -

- Senior role holds the responsibility to supervise and or support and monitor quality of the work of team colleagues

- Advise, train and support users of the global Regulatory Information Management (RIM) systems and procedures as per the client requirements.

- Accurate completion of more complex or non-routine data maintenance tasks to agreed schedule

- Ensure own work and that of team is compliant with data standards and defined procedures

- Ensure defined quality control procedures are followed and appropriate actions taken following any issues identified during routine quality monitoring activities.

- Troubleshoot problems when required and propose appropriate solutions

- Identify areas for improvements/efficiencies in existing processes and contributes to the Regulatory Information Management Systems (RIMS) Change Control Process

- Maintain knowledge of client standards and procedures associated with registration data management and contribute to the definition of new and revised procedures to improve quality and effectiveness

- Routine extraction and transformation of raw data from various Regulatory Information Management Systems (RIMS) for KPI generation in the context of data quality improvement and performance monitoring

Qualification: B.E/B.Tech

Veeva Vault certification mandatory

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