Pharma openings at GlaxoSmithKline Pharmaceuticals Ltd

Pharma openings (04) at GlaxoSmithKline Pharmaceuticals Ltd

GlaxoSmithKline Pharmaceuticals Ltd. is looking for B.Pharma, M.Pharma candidates for the following posts. Please check the details to apply.

Company Profile

GlaxoSmithKline is one of the world’s leading pharmaceutical and healthcare companies, with statisticians and programmers working at UK and US R&D sites, and worldwide. In recognition of the developing sophistication and technical requirements of the programming role, the Clinical Programming department was formed as a standalone department within the broader Clinical Statistics group 18 months ago, covering all phases of clinical drug development and commercialization in a wide range of therapeutic areas.

People are at the heart of everything we do. We aim to bring differentiated, high-quality, and high-performing healthcare products to those who need them with our global businesses, scientific and technical know-how, and talented people.

Bringing innovative products and improving access to them is critical to helping build stronger, healthier communities. We leverage our legacy of over 90 years in India to help transform people’s health through our extensive product portfolio that includes prescription medicines and vaccines. We are the leaders in anti-infectives and dermatology in the pharmaceuticals industry and in vaccines too we are the leaders in the private segment.

Jobs Details

Title: Regulatory Specialist, RRDM

Qualification: B.Pharma, M.Pharma

Experience: 4-6 years experience

Location: Bengaluru

Salary: Not Disclosed

Openings: 04

Skills: Drug Regulatory Affairs, Regulatory Information Management System, Veeva Vault, RIMS, Document Management

Roles and Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

  • Accurate completion of routine data maintenance tasks to agreed schedule
  • Ensure your own work is compliant with data standards and defined procedures
  • Ensure defined quality control procedures are followed
  • Capable of performing routine data extraction from RIMS to support KPI generation
  • 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 US/UK submissions and associated correspondence into established regulatory document management system(s).
  • Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
  • Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
  • Working on special projects as required in response to internal and external customer requests.
  • Support for IT related activities

GQA Activities

  • Accurate completion of routine data maintenance tasks to agreed schedule
  • Ensure your own work is compliant with data standards and defined procedures
  • Ensure defined quality control procedures are followed

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.

Desired Candidate Profile
  • 4-6 years experience in delivering business operational support (in the pharmaceutical industry, life sciences research, or regulatory). Have worked on regulatory submission, have fair knowledge on the CAPA and audit reports
  • Demonstrated ability to proactively manage workload, timelines, and identify priorities.  Build relationships with relevant internal functions.
  • Proven ability to work on multiple projects simultaneously.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.
  • Has worked successfully with a complex computer system
  • Interacts with customers to ensure compliance with regulatory records and data management requirements

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