Senior Specialist, 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 PV Ops, the Senior Specialist, Drug Safety will support individual case safety report (ICSR) processing and ensure a high level of quality of safety cases. The successful candidate will work independently, playing a critical role in PV Case management to improve case quality, reconcile safety data and diving into ICSR processing activities.

Responsibilities

• Data entry of ISCRs for select CRISPR programs
• Quality Control of ICSRs for select CRISPR programs
• Ensure timely submission and compliance of assigned ICSRs to global regulatory authorities, business partners, CROs and other parties.
• Reconcile safety data with third parties.
• Work closely with PV leadership to ensure PV compliance and inspection readiness.
• Develop and maintain data entry guidelines and safety reporting forms
• Develop and maintain training materials for data entry of ICSRs
• Monitoring of ICSRs in workflow and managing processing timelines
• As needed, support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with functional leaders and stakeholders to recommend practical, high-impact solutions for PV case processing activities
• Support ongoing PV initiatives and projects assigned by PV Leadership

Minimum Qualifications

• Bachelor's degree in nursing, pharmacy, or other life sciences field
• Minimum 5 years of experience in managing end-to-end ICSR case processing activities either at a Sponsor company or through PV vendor(s)
• Knowledge of FDA, ICH, EU regulations and requirements
• Meticulous attention to detail
• Proficiency in MedDRA and WHO Drug dictionaries.
• Experience with Veeva safety database, EDC systems.
• Strong ability to prioritize and remain organized within a dynamic and ever-changing environment
• Excellent verbal and written communication skills, strong attention to detail, and prior experience working cross-functionally.

Preferred Qualifications

• Oncology and/or Cell & Gene Therapy experience preferred
• 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.

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 Specialist: Base pay range of $105,000 to $115,000+ 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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