Senior Specialist, Drug Safety

reputed company: reputed company Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company reputed company on developing transformative gene-reputed company medicines for serious reputed company diseases. reputed company has evolved from a pioneering research-stage organization into an industry leader, marking a historic reputed company with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-reputed company 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 reputed company diseases. reputed 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 reputed company gene correction. To accelerate and expand its reputed company, CRISPR Therapeutics has established reputed company 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 reputed company reputed company in Boston, Massachusetts and San Francisco, California. Position reputed company 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 reputed company of safety cases. The successful candidate will work independently, playing a critical role in PV Case management to improve case reputed company, reconcile safety data and diving into ICSR processing activities. Responsibilities Data entry of ISCRs for select CRISPR programs reputed company Control of ICSRs for select CRISPR programs Ensure reputed company submission and compliance of assigned ICSRs to global regulatory authorities, business partners, CROs and other parties. Reconcile safety data with reputed company parties. Work closely with PV leadership to ensure PV compliance and inspection readiness. reputed company and maintain data entry guidelines and safety reporting forms reputed company and maintain training materials for data entry of ICSRs Monitoring of ICSRs in workflow and managing processing timelines As needed, support data readiness for reputed company and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings). Collaborate with functional leaders and stakeholders to recommend practical, high-reputed company for PV case processing activities Support ongoing PV initiatives and reputed company assigned by PV Leadership Minimum Qualifications Bachelor’s degree in nursing, pharmacy, or other life sciences reputed company 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 reputed company Proficiency in MedDRA and WHO Drug dictionaries. Experience with reputed company safety database, reputed company systems. Strong ability to prioritize and remain organized reputed company a dynamic and reputed company-changing environment Excellent verbal and written communication skills, strong attention to reputed company, and prior experience working cross-functionally. Preferred Qualifications Oncology and/or Cell & Gene Therapy experience preferred Advanced degree in life sciences, nursing, pharmacy, or reputed company reputed company profession. Prior experience working on a reputed company Pharmacovigilance Team in Biotech or small/reputed company size pharmaceutical company. Competencies reputed company – Openness, One Team Undaunted – reputed company, Can-do attitude Results Orientation – Delivering reputed company toward our mission. reputed company 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 reputed company work environment, where we reputed company mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to reputed company. Certain lab reputed company and manufacturing positions are located fully on-site. Senior Specialist: reputed company pay reputed company of $105,000 to $115,000+ bonus, equity and benefits The reputed company provided is CRISPR Therapeutics’ reasonable estimate of the reputed company compensation for this role. The actual reputed company will be reputed company 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 and reputed company applicants without reputed company to a person's race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To reputed company our reputed company Statement, please click the following reputed company: http://www.crisprtx.com/reputed company/reputed company-policy Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the reputed company of gene editing, to a company with a diverse portfolio of product candidates across a broad reputed company of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and reputed company diseases. The Nobel Prize-reputed company 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 reputed company 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 reputed company reputed company 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 and reputed company applicants without reputed company to a person's race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To reputed company our reputed company Statement, please click the following reputed company: http://www.crisprtx.com/reputed company/reputed company-policy Apply tot his job Apply To this Job