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 management, communications, and training related to new or revised standards and procedures. Support cross-functional quality, compliance, and operational excellence initiatives.

Who You Are You are a pharmacovigilance professional with experience in ICSR processing, global safety regulations, and process management who is passionate about driving quality, compliance, and operational excellence. You are skilled at translating complex regulatory and business requirements into practical processes, procedures, training, and system solutions while building strong partnerships across safety, quality, business, and technology functions. You are a proactive problem-solver with strong organizational and communication skills who thrives in a dynamic environment and is committed to continuous improvement, inspection readiness, and supporting patient safety.

Required Skills Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline. Minimum 5 years of Drug Safety or Pharmacovigilance experience in pharmaceutical, biopharmaceutical, or CRO environments. Working knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements. Experience authoring and maintaining pharmacovigilance procedures and process documentation. Ability to interpret regulatory requirements and assess operational impacts. Experience translating business needs into system requirements and supporting validation activities.

Preferred Skills Experience supporting safety system enhancements and UAT activities. Inspection readiness, audit support, and regulatory interaction experience. Experience working with cross-functional global project teams. Advanced degree in a relevant scientific discipline. Pay is based on location.

Job Level: Management Additional Information The base compensation range for this role is: $-$Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on…