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 current 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 recent and revised procedures to im

📌 Reg Information Management Bengaluru
🏢 GSK
📍 Bengaluru