Job Description:
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.
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.
Minimum Qualifications
- 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 datarelated issues.
- Excellent written and verbal communication skills; able to convey complex concepts clearly.
- Strong organizational, prioritization, and projectmanagement 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 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
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 Manager, Drug Safety: Base pay range of $140,000 to $155,000+ 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.
