Senior/Executive Medical Director, Pharmacovigilance

Role Summary

Senior/Executive Medical Director, Pharmacovigilance. Oversees all safety and pharmacovigilance activities in clinical development and post-marketing surveillance, ensuring medical safety assessments, regulatory reporting, risk management, and communication of safety information globally. Manages safety activities including external suppliers and translates a safety mindset across the organization.

Responsibilities

• Establish and maintain safety governance oversight for all CRISPR Therapeutics products
• Provide hands-on leadership and expertise in all PV matters and drive a safety mindset across teams
• Collaborate with clinical, medical, quality, regulatory, and other stakeholders to oversee safety and PV issues, including study protocols, development plans, INDs/CTAs/BLAs, and other PV activities
• Plan and forecast global PV resources and budget; coordinate with groups on resource needs
• Interact with internal and external colleagues to develop PV programs and processes to meet regulatory reporting requirements
• Manage PV Operations and provide strategic direction for PV efforts
• Lead process improvements within global pharmacovigilance, including technology assessment and implementation
• Oversee PV consultants on aggregate reporting, risk-benefit management, signal detection, and risk mitigation for clinical and post-marketing products
• Ensure regulatory compliance of PV operations
• Lead and support health authority and development partner audits
• Implement global process standardization and continuous improvement

Qualifications

• MD degree or equivalent
• 3+ years of clinical practice experience
• At least 6 years of direct pharmaceutical industry experience
• Preferred: experience in both biotech and pharmaceutical companies

Skills

• Cross-functional collaboration and relationship building
• Safety governance and risk management expertise
• Regulatory knowledge across PV, clinical development, and quality
• Strategic planning and resource management
• Process improvement and change management

Education

• MD degree or equivalent

Additional Requirements

• Location considerations and on-site expectations as applicable
• Travel requirements not specified in the source