Associate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)
Arrowhead Pharmaceuticals
June 30, 2026
Remote friendly (San Diego, CA)
United States
Operations
The Associate Director/Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, maintaining inspection readiness and a robust global compliance program.
Responsibilities:
- Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
- Develop and implement a comprehensive PV quality assurance strategy aligned with organizational goals.
- Develop/oversee end-to-end PV quality assurance processes to ensure compliance with regulatory requirements and internal policies.
- Provide GVP support for clinical, post-marketing, and commercial activities to protect patient safety, maintain data integrity, and support Quality Systems implementation.
- Monitor industry trends/regulatory changes and best practices for continuous improvement.
- Monitor vendor KPIs and implement measures to enhance CRO/vendor quality.
- Lead development, review, and maintenance of PV quality assurance SOPs.
- Manage team performance including training, mentoring, and evaluations.
- Conduct internal audits and collaborate with internal/external partners during inspections.
- Develop quality metrics, prepare reports to senior management, and drive risk assessment/mitigation.
- Oversee CAPA development, execution, closure, and escalation as needed.
Requirements:
- 8 years pharmacovigilance/drug safety experience; 6 years in a quality assurance/compliance role.
- Bachelor’s degree in a related scientific field.
- Strong understanding of global pharmacovigilance regulations, guidelines, and best practices.
- Proven leadership/people management experience.
- Excellent written/verbal communication and cross-functional stakeholder management.
- Detail-oriented; strong analytical and problem-solving skills.
- Experience with internal audits and regulatory inspections (desirable).
- Proficiency with pharmacovigilance databases and software.
Preferred:
- Advanced degree in pharmacy, life sciences, or related field.
Benefits/Instructions:
- California pay range: $180,000 USD - $230,000 USD.
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
- Develop and implement a comprehensive PV quality assurance strategy aligned with organizational goals.
- Develop/oversee end-to-end PV quality assurance processes to ensure compliance with regulatory requirements and internal policies.
- Provide GVP support for clinical, post-marketing, and commercial activities to protect patient safety, maintain data integrity, and support Quality Systems implementation.
- Monitor industry trends/regulatory changes and best practices for continuous improvement.
- Monitor vendor KPIs and implement measures to enhance CRO/vendor quality.
- Lead development, review, and maintenance of PV quality assurance SOPs.
- Manage team performance including training, mentoring, and evaluations.
- Conduct internal audits and collaborate with internal/external partners during inspections.
- Develop quality metrics, prepare reports to senior management, and drive risk assessment/mitigation.
- Oversee CAPA development, execution, closure, and escalation as needed.
Requirements:
- 8 years pharmacovigilance/drug safety experience; 6 years in a quality assurance/compliance role.
- Bachelor’s degree in a related scientific field.
- Strong understanding of global pharmacovigilance regulations, guidelines, and best practices.
- Proven leadership/people management experience.
- Excellent written/verbal communication and cross-functional stakeholder management.
- Detail-oriented; strong analytical and problem-solving skills.
- Experience with internal audits and regulatory inspections (desirable).
- Proficiency with pharmacovigilance databases and software.
Preferred:
- Advanced degree in pharmacy, life sciences, or related field.
Benefits/Instructions:
- California pay range: $180,000 USD - $230,000 USD.
- Candidates must have current, valid authorization to work in the country where this role is located.