Senior Specialist, Drug Safety

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.
• Monitor 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.

Requirements

• 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)
• 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

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

Skills

• 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.

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.

Pay

Senior Specialist: Base pay range of $105,000 to $115,000+ bonus, equity and benefits

Schedule

Certain lab based and manufacturing positions are located fully on-site.