Senior Manager, Drug Safety

Responsibilities

• Oversee daily (ICSR) processing activities, escalating cases when necessary and performing quality checks to ensure compliance
• Safety Database management and oversight (e.g. Study configuration, system updates and enhancements, MedDRA, WhoDRUG)
• Collaborate with internal partners and external collaborators to actively manage and optimize safety data flow
• Develop and implement Drug Safety SOPs and maintain compliance to internal procedures
• Train drug safety teams on established procedures and oversee compliance
• Serve as the subject matter expert for ICSR intake processes and regulatory expectations, including presentations for Development Leadership
• Lead aggregate safety reporting activities (DSUR)
• Coordinate Safety Governance
• Create, track, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring and adherence to drug safety SOPs internally
• Ensure compliance oversight of Pharmacovigilance Agreements
• Support audits and inspections as assigned

Requirements

• 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 and verbal communication skills; able to convey complex concepts clearly
• Strong organizational, prioritization, and project-management capabilities
• Demonstrated ability to work collaboratively across functions and with external partners
• Strong attention to detail and commitment to data quality and compliance

Qualifications

• Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession
• Prior experience working on a nimble Pharmacovigilance Team in Biotech or small/medium size pharmaceutical company
• Cell and Gene Therapy / Oncology Experience

Skills

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems
• Entrepreneurial Spirit – Proactive. Ownership mindset

Benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

Pay

$140,000 to $155,000+ bonus, equity and benefits

Schedule

Flexible remote work with at least three days on-site per week