Senior Medical Scientist, Drug Safety

Role Summary

The Senior Medical Scientist, Drug Safety provides operational and scientific support in managing the development, implementation and oversight of Arrowhead investigational products, including safety governance, surveillance procedures, safety reporting, advanced safety analytics, and timely aggregate safety reports in compliance with internal SOPs and FDA/global requirements.

Responsibilities

• Safety Science Responsibilities
  • Review potential safety observations and signals; contribute to Safety Review Committee and Governance; prepare and assess safety data for ongoing periodic reviews; provide recommendations for Executive Safety Committee
  • Prepare periodic aggregate safety reports (PSUR, DSUR, FDA IND Annual Report, etc.)
  • Perform routine signal detection and evaluate safety signals
  • Stay up to date on relevant regulations
  • Develop and update Safety Surveillance Plans for assigned products
  • Support safety sections ofClinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure and Risk Management Plan
  • Assist in quality assurance activities, including deviation reports
  • Monitor SAE reconciliation with PV vendor and study CRO
  • Assist with regulatory inspections preparation related to safety/pharmacovigilance
  • Support activities for BLA/NDA or global marketing filings
• Medical Review Responsibilities
  • Perform Medical Review on SAE/SUSAR if applicable
  • Conduct active case follow-up with clinical operations, investigators, and sites as needed

Qualifications

• Medical Degree: MD/DO
• 8 years in the pharmaceutical industry or CRO
• 5 years in drug safety operations, pharmacovigilance, or related experience
• Experience in Signal Detection and Safety Data Analytics
• Strong safety science experience with data analysis and visualization platforms/tools; ability to translate safety science into risk mitigation and insights
• Strong working knowledge of FDA and international adverse event regulations (ICH, EMA GPV, GCP, etc.)
• Strong working knowledge of ARGUS or other safety databases; MedDRA/WHODrug coding experience
• Experience with aggregate reports (DSURs, IND Annual Reports) or post-marketing reports (PSUR/PBRER, PADERs)
• Strong interpersonal skills and ability to interact with cross-functional teams

Education

• Medical Degree: MD/DO

Additional Requirements

• Onsite role based in San Diego, CA