Senior Specialist, Drug Safety

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 ICSR for select CRISPR programs Ensure timely submission and compliance of assigned ICSR 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 ICSR Monitor ICSR 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: #J-18808-Ljbffr Scorpion Therapeutics