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    Technical Associate II - Bengaluru, India - 14260 GSK India Global Services Private Limited

    14260 GSK India Global Services Private Limited
    14260 GSK India Global Services Private Limited Bengaluru, India

    1 week ago

    Default job background
    Full time
    Description

    Key Responsibilities/Activities (dependent on areas supported by each TA)

  • Assist GPOs/SPLs to provide strategic oversight for enterprise PV processes.
  • Assist GPOs/SPLs to deliver innovative, efficient, holistic, end-to-end safety processes that are compliant with global PV regulations and reflect enterprise business needs, including Process Simplification.
  • Provide operational, technical and maintenance support of appropriate PVE Workstreams
  • Undertake Template Manager Role to support PV documentation in VeeVa Vault (Regulatory and Clinical)
  • Support interaction between PVE and 3rd Party Vendor Activities for Aggregate Report management
  • Provide support for metric collection, compilation and reporting
  • Provide support for Management Monitoring
  • Manage daily triage of group mailboxes
  • Contribute to process improvement
  • Undertake role of Subject Matter Expert, when required
  • Business owner of document management systems
  • Review content on PVE owned webpages and ensure materials are up to date and fully operational
  • Support Signal detection, including CVW
  • Support Eudravigilance activities
  • Support RMP and Targeted Safety Study (TSS)/Post Approval Safety Study (PASS) activities
  • Support eTMF
  • Support Medical Devices
  • Support Case Awareness Tool/Autolistedness profile/TOI/MedDRA
  • Support Medication Error activities
  • Support PIER Report generation/meta data change requests
  • Support PRION alerts and QRG maintenance
  • Provide oversight of local Reference Safety Information updates and address queries
  • Provide support for training, inspections, and audits

    • Key Skills

  • Excellent computer skills including Word, Excel, Internet/Intranet, document management systems
  • Excellent organisational skills
  • Demonstrates ability to work with tight deadlines under pressure, while maintaining a high level of accuracy, attention to detail and integrity
  • Functions as a team player
  • Demonstrates ability to effectively communicate (written and verbal)
  • Ability to effectively handle and appropriately escalate issues based on risk in a timely manner
  • Awareness of PV processes and global PV regulations
  • Preferred knowledge of process improvement techniques and ability to analyze performance metrics to drive continuous improvement
  • Preferred knowledge of other related disciplines e.g. clinical, regulatory affairs, clinical statistics relevant to aggregate report writing and clinical development
  • Demonstrates ability to be able to work independently, in a flexible manner and adjust to change

    • Experience

  • Bachelor's degree plus 3-4 years' experience providing technical support for a high volume medically oriented or Clinical R&D department in a large corporation. Higher education advantageous.
  • Familiarity with medical/scientific terminology desirable. Need demonstrated proficiency and capability in technical aspects of the role in similar environment.
  • Working knowledge of R&D organisation preferred.

    • Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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