Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Sep 14 2022
Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
The post holder provides cross enterprise technical support within PV Excellence (PVE) and the business, as required.. The post holder supports Global Process Owners(GPOs), Safety Process Leads (SPLs) and the business, by undertaking identified operational tasks. 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.
• Assist the Global Safety Quality Team with issues management, including entry of records into central systems, follow-up on response plans, and generation of quality metrics
• Assist record owners with records management and archiving tasks
• Provide operational, technical and maintenance support of appropriate PVE Workstreams
• Undertake Template Manager Role to support for 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

• Minimum high school diploma or equivalent 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.
• Working knowledge of R&D organisation preferred.

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

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  LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.