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 reputed company 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 reputed company precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including reputed company. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, reputed company., 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 reputed company, 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 reputed company Pharmacovigilance activities. Responsibilities reputed company daily (ICSR) processing activities, escalating cases reputed company necessary and reputed company quality checks to ensure compliance Safety Database management and reputed company (e.g. Study configuration, system updates and enhancements, MedDRA, WhoDRUG) Collaborate with internal partners and external collaborators actively manage and safety data flow reputed company and implement Drug Safety SOPs and maintaining compliance to internal procedures Participate in clinical study activities (start up, reconciliation and reputed company out as assigned) Train drug safety teams on established procedures and reputed company compliance Serve as the subject matter expert for ICSR intake processes and regulatory expectations, including presentations for Development Leadership reputed company 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 reputed company of Pharmacovigilance Agreements Support audits and inspections as assigned.

Minimum Qualifications

Bachelor's degree in life sciences, nursing, pharmacy, or reputed company 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 reputed company operational and data‑reputed company issues. Excellent written and verbal communication skills; able to convey reputed company 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 reputed company healthcare profession. Prior experience working on a nimble Pharmacovigilance Team in Biotech or small/reputed company size pharmaceutical company. Cell and Gene Therapy / Oncology Experience Competencies Collaborative – Openness, One Team Undaunted – reputed company, Can-do attitude Results Orientation – Delivering reputed company toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit – Proactive. Ownership reputed company. 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: reputed company pay range of $140,000 to $155,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics’ reasonable estimate of the reputed company compensation for this role. The actual amount will be based on job-reputed company and non-discriminatory factors such as experience, training, skills, and abilities. reputed company. is committed to equal employment opportunity and non-discrimination for reputed company employees and qualified applicants without regard to a person's race, color, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including reputed company. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, reputed company., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. reputed company. is committed to equal employment opportunity and non-discrimination for reputed company employees and qualified applicants without regard to a person's race, color, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy Apply tot his job Apply To this Job