Senior Specialist, Drug Safety

Role: Senior Specialist in Pharmacovigilance (PV) Case Management supporting CRISPR Therapeutics' gene therapy programs, focusing on improving ICSR processing quality and safety data reconciliation. Responsibilities: manage end-to-end ICSR data entry and QC, ensure timely regulatory submissions, collaborate with PV leadership to maintain compliance and inspection readiness, develop data entry guidelines and training materials, monitor workflow timelines, and support aggregate safety reports (e.g., DSUR, PBRER). Qualifications: Bachelor’s in nursing, pharmacy, or life sciences; minimum 5 years' PV experience managing ICSRs at sponsor or vendor; knowledge of FDA, ICH, EU regulations; proficiency in MedDRA, WHO Drug dictionaries, Veeva, and EDC systems. Preferred: Oncology or Cell & Gene Therapy experience, advanced life sciences degree, prior biotech PV team experience. High-Value: PV case management, regulatory compliance, ICSR processing, data reconciliation, safety reporting, with an emphasis on biotech/pharma safety functions. Work Setup: Hybrid (Boston-based with remote flexibility); no explicit travel required.