Director, Safety Science
Arrowhead Pharmaceuticals
June 24, 2026
Remote friendly (San Diego, CA)
United States
Medical Affairs
The Director, Safety Science provides leadership to safety scientists and scientific support for managing the development, implementation, and oversight of Arrowhead investigational products.
Responsibilities:
- Lead and supervise Safety Scientists; approve documents/deliverables; train team.
- Monitor safety activities; participate in TST/PST and safety governance.
- Review/prepare safety data for governance; present safety data.
- Prepare periodic aggregate safety reports (e.g., DSUR, FDA IND Annual Report).
- Lead signal detection/trend recognition; identify/evaluate safety signals (case reports and aggregate data).
- Manage vendors/CROs; budget review and CRO coordination; oversee local safety reporting and SAE reconciliation.
- Develop/update Clinical Risk Management Plans; Safety Monitoring Plans; safety surveillance and signal detection procedures.
- Support protocol/CSR/CORE data sheet safety sections, ICF/CRF/Ae/SAE forms, Investigator’s Brochure safety content.
- Provide drug safety case management support; conduct case follow-up; support DSC/DSMB materials.
- Manage CAPA/QMS for safety/PV; support regulatory inspections and BLA/NDA/global marketing filings.
Requirements:
- MD or DO; 10+ years in drug safety operations/pharmacovigilance.
- Experience in Safety/PV operations; case management (ARGUS or other) and MedDRA/WHO coding.
- Aggregate report experience (DSUR/IND Annual; PSUR/PBRER/PADER).
- Critical: pre/post-marketing signal detection and safety data analytics.
- Knowledge of FDA and international AE reporting regulations (ICH/EMA GPV/GCP).
- Quality/compliance, clinical trial safety document experience, Integrated Safety Summary reviews, regulatory submissions, audits.
- Strong organizational skills; proficiency in Word/Excel/Outlook.
Preferred:
- Data mining and extensive analyses; oversight of safety science deliverables.
Compensation:
- California pay range: $240,000–$260,000.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Lead and supervise Safety Scientists; approve documents/deliverables; train team.
- Monitor safety activities; participate in TST/PST and safety governance.
- Review/prepare safety data for governance; present safety data.
- Prepare periodic aggregate safety reports (e.g., DSUR, FDA IND Annual Report).
- Lead signal detection/trend recognition; identify/evaluate safety signals (case reports and aggregate data).
- Manage vendors/CROs; budget review and CRO coordination; oversee local safety reporting and SAE reconciliation.
- Develop/update Clinical Risk Management Plans; Safety Monitoring Plans; safety surveillance and signal detection procedures.
- Support protocol/CSR/CORE data sheet safety sections, ICF/CRF/Ae/SAE forms, Investigator’s Brochure safety content.
- Provide drug safety case management support; conduct case follow-up; support DSC/DSMB materials.
- Manage CAPA/QMS for safety/PV; support regulatory inspections and BLA/NDA/global marketing filings.
Requirements:
- MD or DO; 10+ years in drug safety operations/pharmacovigilance.
- Experience in Safety/PV operations; case management (ARGUS or other) and MedDRA/WHO coding.
- Aggregate report experience (DSUR/IND Annual; PSUR/PBRER/PADER).
- Critical: pre/post-marketing signal detection and safety data analytics.
- Knowledge of FDA and international AE reporting regulations (ICH/EMA GPV/GCP).
- Quality/compliance, clinical trial safety document experience, Integrated Safety Summary reviews, regulatory submissions, audits.
- Strong organizational skills; proficiency in Word/Excel/Outlook.
Preferred:
- Data mining and extensive analyses; oversight of safety science deliverables.
Compensation:
- California pay range: $240,000–$260,000.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.