Manager, Drug Safety - ICSR Processes

Preference will be given to candidates who can work in a hybrid arrangement, with weekly presence onsite at our headquarters in Cambridge, MA . However, remote work may be available for highly qualified candidates residing within the United States. About This Role The Manager, Drug Safety, ICSR Processes is responsible for defining, designing, maintaining, and continuously improving global Individual Case Safety Report (ICSR) process standards, conventions, and procedural documentation across clinical and post-marketing safety activities. This role serves as a subject matter expert for ICSR processes, ensuring quality, compliance, inspection readiness, and effective use of pharmacovigilance systems supporting global safety operations. What You Will Do Define, design, write, maintain, and improve global case processing standards, processes, and data handling conventions. Assess end-to-end ICSR processes to identify gaps, inefficiencies, compliance risks, and improvement opportunities. Partner with Case Processing Oversight to analyze quality trends and drive continuous improvement initiatives. Define and maintain business requirements for ICSR intake and case processing activities and support implementation with systems and IT teams. Conduct impact assessments and User Acceptance Testing (UAT) for safety system enhancements and changes. Support SOPs, job aids, training content, inspection readiness activities, audits, and health authority interactions. Lead process change mana