Job Description:Position SummaryReporting 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 diving into ICSR processing activities.
Responsibilities- Data entry of ISCRs for select CRISPR programs
- Quality Control of ICSRs for select CRISPR programs
- Ensure timely submission and compliance of assigned ICSRs 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 ICSRs
- Monitoring of ICSRs in workflow and managing processing timelines
- As needed, 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 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 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, strong attention to detail, and prior experience working cross-functionally.
Preferred Qualifications- Oncology and/or Cell & Gene Therapy experience preferred
- 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.
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 Specialist: Base pay range of $105,000 to $115,000+ 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.
