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
Position Summary
The job holder has the responsibility for ensuring oversight of the medical review activities performed by the Global Service Provider (GSP), ensuring the work is aligned with the requirements and expectations of the sponsor (GSK). The role will work across GSK’s Safety Evaluation and Risk Management (SERM) teams, the GSP’s ICSR medical reviewers, and the ICSR Management teams at both GSK & GSP to continually improve the standard ways of working, ensure the quality of medical review activities including the listedness/expectedness and causality assessments, and ensure that regulatory requirements and standards are met.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Ensure that the deliverables produced by GSP ICSR medical reviewers meet GSK’s quality standards.
Perform quality checks of activities conducted by ICSR medical reviewers, and deliverables prepared by ICSR medical reviewers, to confirm that cases reported to health authorities satisfy regulatory and company requirements.
Meet with GSP medical review leadership on a regular and ad hoc basis to evaluate medical review activities including quantity of cases, quality of medical review deliverables, difficult cases with opportunities for learning, suggest process improvements, etc.
Establish and maintain appropriate training plans for GSP medical reviewers to support competency and compliance. This training plan will include ICSR medical review processes but also content related to the products being medically reviewed and evolving regulatory guidelines / expectations.
Be involved in training SERM, GSP and ICSR case processing teams on updates to the medical review process when applicable.
Serve as a liaison between the SERM teams, case processing teams and the ICSR medical review teams, facilitating communication and meetings as required, and ensuring alignment where needed.
Promote and implement continuous improvement initiatives for medical review processes and content.
Oversee and/or contribute to investigations of non-compliance, perform gap analyses, and critically evaluate data and metrics generated by the GSP.
Communicate key performance indicators (KPIs) and regularly escalate identified issues or risks to the appropriate management personnel (Global Process Owner Job Description (1.0) Feb 2025 Template Doc ID: VQD-TEMPL-016659 Parent Doc ID: VQD-SOP-083440 ICSR Management, Senior Director ICSR Medical Review, Global Head of PV Operations and/ or SERM VPs).
Provide medical support to GSP medical reviewers in the assessment of cases. Liaise between ICSR case management, GSP medical review and SERM on an ad hoc basis to address challenging cases (either due to medical content or process concerns).
Operate effectively within a complex matrix environment to ensure high quality execution of case management activities in compliance with internal standards and external regulatory requirements; where deficiencies are identified, facilitate root cause investigations and develop corrective and preventive actions (CAPAs).
When required, liaise with local operating companies (LOCs) regarding medical review and support the development of processes to satisfy local regulatory requirements.
When required, present information regarding the medical review strategy at internal forums, audits, and inspections.
Ensure inspection readiness.
Demonstrate and uphold GSK’s values in all activities.
Why you?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
• Minimum of 9 to 12 years of Medical review (all types of cases)
• Expertise in listedness/expectedness and causality assessment, understanding of MedDRA coding conventions,
• Expertise in quality management and KPI monitoring
• Strong understanding of the impact of Medical Review of ICSRs on signal detection, periodic reports, responses to regulatory authority queries and other downstream safety surveillance and risk management activities.
• Good medical judgement and ability to make sound, evidence-based medical decisions
• Clear understanding of clinical development process
• Good understanding of global pharmacovigilance-related regulations
• Clear understanding of drug approval process in major countries
• Strong English written and verbal communication skills
• Strong stakeholder engagement
• Demonstrated leadership abilities
• Ability to influence in a matrix environment.
Preferred Qualification
If you have the following characteristics, it would be a plus
- Advanced clinical degree (MD, PharmD) or postgraduate qualification in a relevant field.
- Experience in signal detection, aggregate reporting and contribution to Risk Management Plans.
- Prior people management or team lead experience within PV Operations.
- Familiarity with regulatory expectations for inspections and ability to support audit responses.
- Experience with pharmacovigilance guidelines and international requirements.
- Experience working with external partners such as CROs or safety vendors.
What you will bring
- A practical, patient-focused approach to safety review and risk assessment.
- Clear scientific judgement and attention to detail.
- Collaborative mindset and the ability to influence across functions.
- Willingness to learn and help develop others.
- Commitment to high standards of quality and regulatory compliance.
Apply now to join a team where your medical expertise will help protect patients and shape safer medicines. We welcome candidates from diverse backgrounds and encourage you to apply if you meet the qualifications.
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-adjustments@gsk.com to discuss your needs.
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