Senior Manager, Drug Safety

Senior Manager, Drug Safety

Reporting to the Head of Pharmacovigilance Operations, the Senior Manager, Drug Safety will play a pivotal role in compliance oversight, end-to-end case management and author drug safety SOPs. The successful candidate will work cross-functionally to support Individual Case Safety Report (ICSR) processing and compliance and vendor management. This role will play part in ensuring continuity across all Pharmacovigilance activities.

Responsibilities

• Oversee daily (ICSR) processing activities, escalating cases when necessary and perform 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 actively manage and safety data flow
• Develop and implement Drug Safety SOPs and maintaining compliance to 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 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 Scheduling
• 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.

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 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.

Preferred 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

Competencies

• 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.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Senior Manager, Drug Safety: Base pay range of $140,000 to $155,000+ bonus, equity and 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.

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

CRISPR Therapeutics