Arrowhead Pharmaceuticals · 5 hours ago
Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)
San Diego, California, United States
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $230K/yr
10+ years expArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Associate Director/Director of Drug Safety & Pharmacovigilance Quality & Compliance is responsible for overseeing quality and compliance activities, ensuring inspection readiness, and managing a team to enhance the safety and quality of pharmaceutical products.
BiotechnologyHealth CareNanotechnologyPharmaceutical
No H1B
Responsibilities
Provide strategic guidance and leadership to the pharmacovigilance quality assurance team
Develop and implement a comprehensive quality assurance strategy aligned with organizational goals
Develop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/procedures
Proactively provide Good Pharmacovigilance Practice (GVP) support for clinical, post marketing and commercial activities including PV/ safety systems to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems
Monitor industry trends, regulatory changes, and best practices to ensure continuous improvement of quality assurance processes
Monitor vendor key performance indicator (KPI) metrics and implement measures to enhance the quality of CROs and vendors
Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activities
Ensure that SOPs are consistent with current regulations, guidelines, and industry standards
Manage a team of quality assurance professionals, including training, mentoring, and performance evaluations
Foster a collaborative and high-performance work environment to achieve departmental objectives
Conduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirements
Collaborate with internal audit teams and external partners during regulatory inspections and audits
Develop and implement key quality metrics to assess the effectiveness of pharmacovigilance processes
Prepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvement
Collaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities. Identify areas of potential risk and implement strategies to mitigate them proactively
Drive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activities
Regularly assess quality and compliance initiatives for effectiveness, outcomes, and relevance, and adjust strategy as needed based on results, risks, and feedback
Engage with stakeholders to solicit feedback and implement process enhancements
Monitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV system
Oversee corrective and preventative actions (CAPA) development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance
Contribute to drug safety and pharmacovigilance issue management to support early issue detection, CAPA development and completion tracking, and effectiveness assessment for PV systems
Qualification
Required
10 years of experience in pharmacovigilance or drug safety, with 9-10 years in a quality assurance or compliance role
Bachelor's Degree in a related scientific field
Strong understanding of global pharmacovigilance regulations, guidelines, and industry best practices
Proven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staff
Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholders
Detail-oriented with strong analytical and problem-solving capabilities
Experience in conducting internal audits and managing regulatory inspections is desirable
Proficiency in using pharmacovigilance databases and software
Preferred
Advanced degree in pharmacy, life sciences, or a related field
Benefits
Competitive salaries
Excellent benefit package
Company
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.45BKey Investors
Sarepta TherapeuticsSixth StreetSilence Therapeutics
2026-01-07Post Ipo Equity· $200M
2026-01-07Post Ipo Debt· $625M
2024-11-26Post Ipo Equity· $325M
Leadership Team
Christopher Anzalone
President and Chief Executive Officer
Recent News
2026-01-14
Company data provided by crunchbase