Technical Associate II

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Job Purpose:

• Provide cross-enterprise technical support within PV Excellence (PVE) and the business, as required.
• Support Global Process Owners (GPOs), Safety Process Leads (SPLs), and the business by undertaking identified operational tasks.
• Assist GPOs/SPLs in providing strategic oversight for enterprise PV processes.
• Contribute to delivering innovative, efficient, holistic, end-to-end safety processes that comply with global PV regulations and reflect enterprise business needs.
• Provide operational, technical, and maintenance support for appropriate PVE workstreams.

Key Responsibilities:

PV Excellence

• Act as Template Manager to support PV documentation in Veeva Vault (Regulatory and Clinical).
• Support interaction between PVE and third-party vendor activities for Aggregate Report management.
• Provide support for metric collection, compilation, and reporting.
• Assist with Management Monitoring activities.
• Manage access (Submission Portal, Aggregate Report shared drive, Group Management Portal, Citrix).
• Daily triage and management of group mailboxes.
• Contribute to process improvement initiatives.
• Act as Subject Matter Expert when required.
• Serve as business owner for document management systems.
• Review and maintain content on PVE-owned webpages to ensure accuracy and functionality.
• Support signal detection activities, including CVW and EMA publication reviews for signal-related data.
• Assist with Eudravigilance activities.
• Support RMP and Targeted Safety Study (TSS)/Post Approval Safety Study (PASS) activities, including RMP coordination.
• Provide support for eTMF and Medical Devices.
• Assist with Case Awareness Tool, Autolistedness profile, TOI, MedDRA, and TFQs.
• Oversee local Reference Safety Information updates and address related queries.
• Support Development Core Safety Information management.
• Assist with Safety Communications processes.
• Provide support for training, inspections, and audits.

Expected Competencies:

• Excellent organizational skills.
• Ability to work under pressure with tight deadlines while maintaining accuracy and integrity.
• Strong team player with effective communication skills (written and verbal).
• Ability to handle and 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 for continuous improvement.
• Preferred understanding of related disciplines (clinical, regulatory affairs, clinical statistics) relevant to aggregate report writing and clinical development.
• Ability to work independently, adapt to change, and maintain flexibility.

Education Requirements:

• Bachelor's degree in health sciences or related disciplines.
• Familiarity with medical/scientific industry desirable.
• Basic understanding of medically oriented tasks and technical support skills.

Job-Related Experience:

• 2–4 years of relevant experience.
• Fluent in English with strong communication skills.
• Excellent computer skills (Word, Excel, Internet/Intranet, document management systems).
• Familiarity with medical/scientific terminology desirable.
• Working knowledge of R\&D organization preferred.

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- to discuss your needs.

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