Global Safety, PV Operations, ICSR Management

GSK

5d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.