Senior Specialist, Drug Safety
CRISPR Therapeutics
19 days ago
Remote friendly (Boston, MA)
United States
Operations
Position Summary
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. Work independently in PV case management to improve case quality, reconcile safety data, and support ICSR processing.
Responsibilities
- Data entry of ICSR 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 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 ICSRs in workflow and manage processing timelines
- Support data readiness for aggregate reports (e.g., DSUR, PBRER, and IDMC listings) as needed
- Collaborate with functional leaders and stakeholders to recommend practical, high-impact solutions for PV case processing
- 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 end-to-end ICSR case processing experience (Sponsor or PV vendor)
- Knowledge of FDA, ICH, and EU regulations and requirements
- Meticulous attention to detail
- Proficiency in MedDRA and WHO Drug dictionaries
- Experience with Veeva safety database and EDC systems
- Strong ability to prioritize and stay organized in a dynamic environment
- Excellent verbal and written communication skills; cross-functional experience
Preferred Qualifications
- Oncology and/or Cell & Gene Therapy experience
- Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession
- Prior experience on a nimble Pharmacovigilance Team in biotech or small/medium pharmaceutical company
Compensation/Benefits
- Senior Specialist: Base pay range of $105,000 to $115,000+ bonus, equity and benefits
Application
- To view our Privacy Statement, click: http://www.crisprtx.com/about-us/privacy-policy
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. Work independently in PV case management to improve case quality, reconcile safety data, and support ICSR processing.
Responsibilities
- Data entry of ICSR 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 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 ICSRs in workflow and manage processing timelines
- Support data readiness for aggregate reports (e.g., DSUR, PBRER, and IDMC listings) as needed
- Collaborate with functional leaders and stakeholders to recommend practical, high-impact solutions for PV case processing
- 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 end-to-end ICSR case processing experience (Sponsor or PV vendor)
- Knowledge of FDA, ICH, and EU regulations and requirements
- Meticulous attention to detail
- Proficiency in MedDRA and WHO Drug dictionaries
- Experience with Veeva safety database and EDC systems
- Strong ability to prioritize and stay organized in a dynamic environment
- Excellent verbal and written communication skills; cross-functional experience
Preferred Qualifications
- Oncology and/or Cell & Gene Therapy experience
- Advanced degree in life sciences, nursing, pharmacy, or related healthcare profession
- Prior experience on a nimble Pharmacovigilance Team in biotech or small/medium pharmaceutical company
Compensation/Benefits
- Senior Specialist: Base pay range of $105,000 to $115,000+ bonus, equity and benefits
Application
- To view our Privacy Statement, click: http://www.crisprtx.com/about-us/privacy-policy