Job Purpose
The information (data and documents) managed by Regulatory Information Management & Data Office is critical to patient
safety, regulatory compliance and effective business operations. Regulatory Information Management & Data Office are
responsible for the accurate encoding of GSK product (Pharmaceuticals and Vaccines) registration information and maintaining
regulatory records to a high standard appropriate to support critical regulated processes including Pharmacovigilance and GMP
compliant product supply. This data also supports the productive operational management of the Regulatory function, worldwide.
The role provides operational support to RIMS end-users.
Key Responsibilities: Describe the key deliverables to be achieved by the post holder and the ongoing
responsibilities of the role.
- Accurate completion of routine data maintenance tasks to agreed schedule
- Ensure own work 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
- Routine/ ad-hoc 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
- Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and
revised procedures to improve quality and effectiveness
- Indexing, abstracting and quality assurance of Health Authority (HA) submissions and associated correspondence into
established regulatory document management system(s).
- Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line
databases.
- Maintain knowledge of GSK standards and procedures associated with registration data management and contribute to the
definition of new and revised procedures to im
📌 Reg. Information Management (Bengaluru)
🏢 GSK
📍 Bengaluru