Senior Medical Scientist
$185,000–$210,000 year
On-siteSan Diego, California, United States
Job Summary
Oversee operational and scientific support for Arrowhead investigational products, managing safety governance, surveillance procedures, and reporting processes including PSURs, DSURs, and FDA IND Annual Reports. Conduct trend recognition, signal detection, and active case follow-up while reviewing potential safety observations for the Safety Review Committee. Develop and update Safety Surveillance Plans, support regulatory inspections, and assist with BLA/NDA filing preparations. Collaborate with cross-functional teams to ensure compliance with FDA and global safety reporting requirements. Base onsite 5x a week in San Diego, CA.
Required Qualifications
- MD or DO Degree
- 8 years in the pharmaceutical industry or CRO
- 5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
- Experience in Signal Detection and Safety Data Analytics
- Strong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into risk mitigation strategies and data visualization insights
- Strong working knowledge of FDA and international adverse event reporting regulations {ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations
- Strong working knowledge of ARGUS case management and medical review processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications, post marketed and premarketed products
- Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
- Strong interpersonal skills with the ability to professionally interact with cross functional team members
- Candidates must have current, valid authorization to work in the country where this role is located
- This position is base onsite 5x a week at Arrowhead's Research & Development site in San Diego, CA
Desired Qualifications
- Experience in the cardiometabolic and/or rare disease space
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