Senior Specialist, Drug Safety

Senior Specialist, Drug Safety

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 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.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.