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Bengaluru, Karnataka, India
Onsite
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.
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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