Global Safety, PV Operations, ICSR Management

Global Safety, PV Operations, ICSR Management

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. This role offers a chance to grow your career while making a real impact on patient safety and supporting GSK’s mission.

• 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.

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

• Advanced degree (Pharm
  
  D, 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.

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

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 bring a respectful, inclusive approach to your work.

Please apply and tell us how your experience can help us ensure safe use of medicines and make a positive impact for patients.

Learn more about the comprehensive benefits program GSK offers US employees.

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, military service or any basis prohibited under federal, state or local law.