Global Safety, PV Operations, ICSR Management

Global Safety, PV Operations, ICSR Management

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

You will lead and manage Individual Case Safety Report (ICSR) activities within Global Safety, ensuring timely and compliant case processing. You will work closely with global teams, vendors, and stakeholders to improve processes and maintain high quality standards. We value clear decision-making, collaboration, and a focus on continuous learning. This role offers a chance to grow your career while making a real impact on patient safety and supporting GSK's mission of uniting science, technology and talent to get ahead of disease together.

Key Responsibilities:

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

• Lead and oversee end-to-end ICSR management, including intake, triage, case processing, medical review, and reporting to health authorities.
• Manage relationships with external vendors and internal partners to ensure service quality and timely delivery.
• Maintain and improve global processes, standard operating procedures, and metrics for case handling.
• Support regulatory submissions, aggregate reporting timelines, and inspection readiness for ICSR activities.
• Provide coaching, mentoring, and training to team members to build capability and ensure consistent quality.
• Drive continuous improvement initiatives and data-driven solutions to increase efficiency and data quality.
  
  

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

Bachelor's degree in life sciences, pharmacy, nursing, or a related field, or equivalent experience.

• Minimum 5 years of direct pharmacovigilance or drug safety experience, including hands-on ICSR processing.
• Minimum of 3 years implementing global pharmacovigilance regulations and reporting requirements.
• Minimum of 3 years of experience working with safety databases and case management systems.
• Minimum of 3 years of line management experience
• Minimum of 2 years of Project Management experience
• Minimum of 2 years of experience mapping processes and authoring written standards.
• Minimum of 2 years experience utilizing Argus, ArisGlobal, or other major safety database platforms.
• Minimum of 1 year of experience participating in global safety inspections or regulatory audits.
• Minimum of 2 years of experience in vendor management or oversight experience in a regulated environment.

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

• Advanced degree (PharmD, MSc, MPH, or similar) or clinical qualification (MD, RN).
• Experience leading global safety inspections or regulatory audits.
• Experience leading teams in a matrix organization or managing distributed teams.
• Project management experience and familiarity with process improvement methods.
• Comfortable working in English and another language relevant to global safety operations.
• Strong written and verbal communication skills and the ability to work in cross-functional teams.
  

Working Model
This role is hybrid. You will be expected to work on-site on a regular basis in the United States, with flexibility to work remotely part of the week as agreed with your manager.

What we value in you
We seek people who are curious, reliable, and collaborative. We value clarity, practical problem solving, and a focus on patient safety. You will be comfortable working with diverse teams and will bring a respectful, inclusive approach to your work. We offer meaningful work, opportunities to grow, and a chance to contribute to a global safety mission.

Ready to make a difference?
We would love to hear from you. Please apply and tell us how your experience can help us ensure safe use of medicines and make a positive impact for patients.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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