Company Overview CRISPR Therapeutics is a biopharmaceutical company developing gene-based medicines for serious human diseases and has advanced from a research-stage organization to an industry leader with the approval of the first CRISPR-based therapy, CASGEVY®.
Position Summary Reporting to the Head of Pharmacovigilance Operations, the Senior Manager, Drug Safety will oversee end-to-end ICSR processing, maintain safety databases, develop drug safety SOPs, and support clinical study activities while ensuring regulatory compliance and vendor management.
Responsibilities Oversee daily ICSR processing activities, escalating cases when necessary and performing quality checks to ensure compliance.
Manage safety database (e.g., study configuration, system updates, MedDRA, WhODrug).
Collaborate with internal and external partners to actively manage and flow safety data.
Develop and implement drug safety SOPs and maintain compliance with internal procedures.
Participate in c...