Senior Manager, Drug Safety

CRISPR Therapeutics•South Boston, MA

2d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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

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.