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Job Details


GlaxoSmithKline (GSK)

Technical Associate, Global Safety-PV Excellence & Compliance

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw
Posted Date: Jun 3 2022

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively

Technical Associate, Global Safety - PV Excellence & Compliance

In this role you will…

  • Assist GPOs/SPLs to provide strategic oversight for enterprise PV processes, 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 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 and Management Monitoring
  • Manage daily triage of group mailboxes and act as a business owner of document management systems
  • Contribute to process improvement
  • Undertake role of Subject Matter Expert, when required
  • Review content on PVE owned webpages and ensure materials are up to date and fully operational
  • Provide support for training, inspections, and audits

Why you?

Qualifications and skills:

  • 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.
  • Excellent computer skills including Word, Excel, Internet/Intranet, document management systems
  • Demonstrated ability to work with tight deadlines under pressure, while maintaining a high level of accuracy, attention to detail and integrity
  • Ability to effectively handle and appropriately escalate issues based on risk in a timely manner as well as good communication skills
  • Awareness of PV processes and global PV regulations
  • Familiarity with medical/scientific terminology desirable.
  • Working knowledge of R&D organisation preferred.

Preferred qualifications and skills:

  • 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
  • Demonstrated ability to be able to work independently, in a flexible manner and adjust to change

Why GSK?

  • Career at one of the leading global healthcare companies
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit, Multisport)
  • Life insurance and pension plan
  • Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic)
  • Private medical package with additional preventive healthcare services for employees and their eligible counterparts
  • Possibilities of development within the role and company’s structure
  • Personalized learning approach (mentoring, online trainings’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external trainings)
  • Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits everyday
  • Free car and bike parking, locker rooms and showers

#LI - GSK #LI-Hybrid

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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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