Senior Manager, Drug Safety
CRISPR Therapeutics
19 days ago
Remote friendly (Boston, MA)
United States
Operations
Responsibilities:
- Oversee daily ICSR processing activities, escalate cases as necessary, and perform quality checks to ensure compliance
- Manage and oversee safety database functions (e.g., study configuration, system updates/enhancements, MedDRA, WhoDRUG)
- Collaborate with internal partners and external collaborators to manage safety data flow
- Develop and implement drug safety SOPs and maintain compliance with internal procedures
- Participate in clinical study activities (start-up, reconciliation, and close-out as assigned)
- Train drug safety teams on established 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/metrics for vendor performance monitoring and adherence to drug safety SOPs
- 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 profession with 10+ years of relevant experience
- Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle
- Veeva Safety Database experience
- Ability to independently identify, analyze, and solve complex operational and data-related issues
- Excellent written/verbal communication; convey complex concepts clearly
- Strong organizational, prioritization, and project-management capabilities
- Ability to work collaboratively across functions and with external partners
- Strong attention to detail; commitment to data quality and compliance
Preferred Qualifications:
- Advanced degree
- Prior experience with a nimble Pharmacovigilance team in biotech or small/medium pharma
- Cell and Gene Therapy / Oncology experience
Benefits/Compensation:
- Base pay range of $140,000 to $155,000+ bonus, equity and benefits
- Oversee daily ICSR processing activities, escalate cases as necessary, and perform quality checks to ensure compliance
- Manage and oversee safety database functions (e.g., study configuration, system updates/enhancements, MedDRA, WhoDRUG)
- Collaborate with internal partners and external collaborators to manage safety data flow
- Develop and implement drug safety SOPs and maintain compliance with internal procedures
- Participate in clinical study activities (start-up, reconciliation, and close-out as assigned)
- Train drug safety teams on established 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/metrics for vendor performance monitoring and adherence to drug safety SOPs
- 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 profession with 10+ years of relevant experience
- Strong understanding of global pharmacovigilance regulations, ICSR processes, and the adverse event lifecycle
- Veeva Safety Database experience
- Ability to independently identify, analyze, and solve complex operational and data-related issues
- Excellent written/verbal communication; convey complex concepts clearly
- Strong organizational, prioritization, and project-management capabilities
- Ability to work collaboratively across functions and with external partners
- Strong attention to detail; commitment to data quality and compliance
Preferred Qualifications:
- Advanced degree
- Prior experience with a nimble Pharmacovigilance team in biotech or small/medium pharma
- Cell and Gene Therapy / Oncology experience
Benefits/Compensation:
- Base pay range of $140,000 to $155,000+ bonus, equity and benefits