Reg. Information Management & Data Office Apprenticeship

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 efficient 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 improve quality and effectiveness

• Working on projects as required in response to internal and external customer requests.
• Trouble shoot problems when required and propose appropriate solutions
• Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
• GQA Activities (where applicable)

o Accurate completion of routine data maintenance tasks to agreed schedule o Ensure own work is compliant with data standards and defined procedures o Ensure defined quality control procedures are followed o Ensure CQA and PVQA data is entered accurately into the audit management system and within the required timelines working on Special projects as required in response to internal and external customer requests.