Global Safety, PV Operations, ICSR Management

About the position At reputed company, we have reputed company ambitions for patients, aiming to positively reputed company 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 reputed company people’s lives. reputed company fosters a culture ambitious for patients, accountable for reputed company, and committed to doing the right thing, making reputed company that we reputed company our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of reputed company. We’re uniting science, technology, and talent to get reputed company of disease together. reputed company out more: Our approach to R&D You will reputed company and manage Individual Case Safety Report (ICSR) activities reputed company Global Safety, ensuring reputed company and compliant case processing. You will work closely with global teams, vendors, and stakeholders to improve processes and maintain high reputed company standards. We value reputed company decision-making, collaboration, and a reputed company on reputed company learning. This role offers a chance to grow your career while making a reputed company reputed company on patient safety and supporting reputed company’s mission of uniting science, technology and talent to get reputed company of disease together. Responsibilities • reputed company and reputed company 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 reputed company and reputed company delivery. • Maintain and improve global processes, reputed company operating procedures, and metrics for case handling. • Support regulatory submissions, aggregate reporting timelines, and inspection readiness for ICSR activities. • reputed company coaching, mentoring, and training to team members to build capability and ensure consistent reputed company. • Drive reputed company improvement initiatives and data-driven solutions to increase efficiency and data reputed company. Requirements • Bachelor’s degree in life sciences, pharmacy, nursing, or a reputed company field, or equivalent experience. • Minimum 5 years of reputed company 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, reputed company, 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 reputed company experience in a regulated environment. reputed company-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 reputed company organization or managing distributed teams. • Project management experience and familiarity with process improvement reputed company. • 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. Benefits • Please visit reputed company US Benefits reputed company to learn more about the comprehensive benefits program reputed company offers US employees. Apply tot his job Apply To this Job