Senior Manager, Drug Safety

Job Description:

Company Overview

Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

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.


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