Senior Specialist, Drug Safety

CRISPR Therapeutics•Boston, MA

2d•$105,000 - $115,000•Hybrid

About The Position

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.

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)
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.

Nice To Haves

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.

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