Associate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)
$180,000–$230,000 year
On-site · San Diego, California, United States
Job Summary
Lead the PV Quality & Compliance function for Arrowhead's Drug Safety & Pharmacovigilance program. Provide strategic direction to PV QA, develop and oversee end-to-end PV QA processes and systems to ensure regulatory compliance, support GVP/GCP/GMP inspections, manage CAPA activities, monitor vendor KPIs and CRO performance, develop SOPs for pharmacovigilance quality assurance, mentor and manage QA staff, conduct internal audits, and collaborate with cross-functional teams to mitigate risks and drive continuous quality improvement.
Required Qualifications
- Bachelors Degree in a related scientific field
- 10 years of experience in pharmacovigilance or drug safety, with 9-10 years in a quality assurance or compliance role
- Strong understanding of global pharmacovigilance regulations, guidelines, and industry best practices
- Proven experience in leading and managing teams, including mentorship and staff development
- Excellent communication skills, both written and verbal, with cross-functional collaboration
- Experience conducting internal audits and managing regulatory inspections (desirable)
- Proficiency in pharmacovigilance databases and software
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