Principal Scientist ICSR Management Full-time

Pharmacovigilance Operations Leader

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.

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities:

• ICSR Management: Argus Configuration for new Programs/Studies, ICSR processing, Case Processing Coding Conventions, Local Operating Companies (LOC) Interactions
• Functional Vendor Oversight: New Market Authorisation, Withdrawal of Market-Authorisation, PAC awareness
• Clinical Trial/Program Interactions for: Study/Program Set up, Study/ Program Maintenance, Study/ Program Close out
• Argus Configuration for Submissions to destinations including Regulatory authorities, Partners, Clinical Research Organisations (CROs), LOCs, Clinical Operations/CROs

The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

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

• Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
• Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)
• Escalate identified problems or issues to the appropriate Management Personnel with PV Operations
• Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
• Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
• Demonstrate GSK values

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree in life sciences or medically related field or previous experience equating to educational requirements
• Minimum 10 years of pharmacovigilance experience, with direct ICSR management experience.
• Support Scientists with enhancement of knowledge and skills for ICSR Management activities
• Leads and oversees Clinical Trial and/or post-Marketed study (PMS) related activities e.g. protocol review, Safety Management Plan review, study/program set-up, reconciliation, end of study unblinding, etc.; supports case management activities for spontaneous event reports.
• Acts as a global PV Operations Leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
• Generates new ideas and proposals for global implementation; contributes to advancement of ICSR management/ program/clinical trial set up/maintenance methodology and processes.
• Prioritize work and time management, in line with business needs.

If you have the following characteristics, it would be a plus:

• Knowledge of GSK products and business structure
• Project management experience
• Ability to map processes and author written standards
• Knowledge and experience with pharmacovigilance systems
• Proven experience developing and delivering high-quality training
• Experience of providing mentoring to other staff

We encourage candidates who want to grow and help advance patient safety to apply. Please submit your CV and a brief note describing your interest and relevant experience. We look forward to hearing from you.

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.

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-adjustments@gsk.com to discuss your needs.

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