Senior Manager, Drug Safety

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®.

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.

• 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 clinical study activities (start‑up, reconciliation, close‑out) as assigned.
• Train drug safety teams on procedures and oversee compliance.
• Serve as subject matter expert for ICSR intake processes and regulatory expectations, including presentations for Development Leadership.
• Lead aggregate safety reporting activities (DSUR).
• Coordinate safety governance scheduling.
• Create, track, and monitor KPIs and metrics for vendor performance and adherence to SOPs.
• Ensure compliance oversight of pharmacovigilance agreements.
• Support audits and inspections as assigned.

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related healthcare profession with 10+ years of relevant experience.
• Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle.
• Experience with Veeva Safety Database.
• Ability to independently identify, analyze, and solve complex operational and data‑related issues.
• Excellent written and verbal communication skills.
• Strong organizational, prioritization, and project‑management capabilities.
• Demonstrated ability to collaborate across functions and with external partners.
• Strong attention to detail and commitment to data quality and compliance.

• Advanced degree in life sciences, nursing, pharmacy, or a related healthcare profession.
• Prior experience on a nimble pharmacovigilance team in a biotech or small/medium‑size pharmaceutical company.
• Experience in cell and gene therapy or oncology.

• Collaboration – openness, one team.
• Undaunted – fearless, can‑do attitude.
• Results orientation – delivering progress toward the mission.
• Sense of urgency in solving problems.
• Entrepreneurial spirit – proactive, ownership mindset.

• Base pay range: $140,000 to $155,000.
• Bonus, equity, and benefits included.
• Remote work flexibility with a requirement of at least three on‑site days per week.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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