Senior Specialist, Drug Safety

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. 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 dive into ICSR processing activities. Responsibilities Data entry of ISCRs for select CRISPR programs. Quality Control of ISCRs for select CRISPR programs. Ensure timely submission and compliance of assigned ISCRs 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 ISCRs. Monitor ISCRs in workflow and manage processing timelines. 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 managing end‑to‑end ICSR case processing activities 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. Prior experience working cross‑functionally. Preferred Qualifications Oncology and/or Cell & Gene Therapy experience. Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession. Prior experience working on a nimble Pharmacovigilance team in a 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. Benefits and Work Flexibility CRISPR Therapeutics promotes a dynamic workplace that balances remote work flexibility with the benefits of in‑person interactions. Employees work at least three days on‑site, fostering mentorship opportunities, cross‑functional communication, and collaborative engagement. Compensation Base pay range: $105,000 to $115,000 plus bonus, equity, and benefits. Equal Opportunity Employment Statement 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. To view our Privacy Statement, please click the following link: #J-18808-Ljbffr