Senior Manager, Drug Safety
CRISPR Therapeutics
July 01, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
Position Summary
Reporting to the Head of Pharmacovigilance Operations, the Senior Manager, Drug Safety will oversee compliance, end-to-end case management, and author drug safety SOPs. Works cross-functionally to support ICSR processing, compliance, and vendor management.
Responsibilities
- Oversee daily ICSR processing; escalate cases as necessary and perform quality checks for compliance
- Manage and oversee safety database (study configuration, system updates/enhancements, MedDRA, WhoDRUG)
- Collaborate with internal and external partners to manage safety data flow
- Develop and implement Drug Safety SOPs and maintain compliance to internal procedures
- Participate in clinical study activities (start-up, reconciliation, close-out as assigned)
- Train drug safety teams on established procedures and oversee compliance
- Serve as SME for ICSR intake processes and regulatory expectations (including presentations)
- Lead aggregate safety reporting activities (DSUR)
- Coordinate Safety Governance Scheduling
- Create, track, and monitor KPIs/metrics for vendor performance and SOP adherence
- Ensure compliance oversight of Pharmacovigilance Agreements
- Support audits and inspections as assigned
Minimum Qualifications
- Bachelor’s degree in life sciences, nursing, pharmacy, or related healthcare; 10+ years relevant experience
- Strong knowledge of global pharmacovigilance regulations, ICSR processes, and adverse event lifecycle
- Veeva Safety Database experience
- Ability to identify/analyze/solve complex operational and data-related issues
- Excellent written/verbal communication
- Strong organizational, prioritization, and project-management skills
- Collaborative across functions and with external partners
- Strong attention to detail; commitment to data quality and compliance
Preferred Qualifications
- Advanced degree in life sciences, nursing, pharmacy, or related healthcare
- Experience on a nimble Pharmacovigilance team in biotech or small/medium pharma
- Cell and Gene Therapy / Oncology experience
Benefits
- Base pay range of $140,000 to $155,000+ bonus, equity and benefits
Reporting to the Head of Pharmacovigilance Operations, the Senior Manager, Drug Safety will oversee compliance, end-to-end case management, and author drug safety SOPs. Works cross-functionally to support ICSR processing, compliance, and vendor management.
Responsibilities
- Oversee daily ICSR processing; escalate cases as necessary and perform quality checks for compliance
- Manage and oversee safety database (study configuration, system updates/enhancements, MedDRA, WhoDRUG)
- Collaborate with internal and external partners to manage safety data flow
- Develop and implement Drug Safety SOPs and maintain compliance to internal procedures
- Participate in clinical study activities (start-up, reconciliation, close-out as assigned)
- Train drug safety teams on established procedures and oversee compliance
- Serve as SME for ICSR intake processes and regulatory expectations (including presentations)
- Lead aggregate safety reporting activities (DSUR)
- Coordinate Safety Governance Scheduling
- Create, track, and monitor KPIs/metrics for vendor performance and SOP adherence
- Ensure compliance oversight of Pharmacovigilance Agreements
- Support audits and inspections as assigned
Minimum Qualifications
- Bachelor’s degree in life sciences, nursing, pharmacy, or related healthcare; 10+ years relevant experience
- Strong knowledge of global pharmacovigilance regulations, ICSR processes, and adverse event lifecycle
- Veeva Safety Database experience
- Ability to identify/analyze/solve complex operational and data-related issues
- Excellent written/verbal communication
- Strong organizational, prioritization, and project-management skills
- Collaborative across functions and with external partners
- Strong attention to detail; commitment to data quality and compliance
Preferred Qualifications
- Advanced degree in life sciences, nursing, pharmacy, or related healthcare
- Experience on a nimble Pharmacovigilance team in biotech or small/medium pharma
- Cell and Gene Therapy / Oncology experience
Benefits
- Base pay range of $140,000 to $155,000+ bonus, equity and benefits