Senior Medical Scientist

Senior Medical Scientist, Drug Safety (base onsite 5x/week at Arrowhead’s Research & Development site in San Diego, CA)

Responsibilities:
- Support safety governance and surveillance, including safety reporting processes and advanced safety analytics
- Prepare expedited/periodic aggregate safety reports; perform trend recognition and routine signal detection/evaluation
- Prepare safety data for Safety Review Committee and Executive Safety Committee; recommend for review/approval
- Develop/update Safety Surveillance Plans; support safety sections of clinical documents (protocols, CSRs, core data sheet, investigators brochure, risk management plan)
- Assist QA activities (e.g., deviation reports) and monitor SAE reconciliation with PV vendor and CRO
- Support regulatory inspection readiness and BLA/NDA/global marketing filing activities
- Perform medical review on SAE/SUSAR (if applicable) and conduct active case follow-up with clinical teams/sites

Requirements:
- MD or DO
- 8+ years pharma industry or CRO
- 5+ years drug safety operations/pharmacovigilance (or equivalent)
- Signal detection and safety data analytics experience
- Strong safety science skills using data analysis/visualization tools
- Working knowledge of FDA and international adverse event reporting regulations (ICH/EMA/GPV/GCP)
- ARGUS case management and medical review processing; safety databases; MedDRA/WHODrug coding
- Experience preparing aggregate reports (DSURs/IND annual; PSUR/PBRER/PADERs)
- Strong interpersonal skills

Preferred:
- Experience in cardiometabolic and/or rare disease

Application instruction:
- Must have current, valid authorization to work in the role location.

Compensation (California pay range): $185,000–$210,000 USD