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Senior Manager of Drug Safety
1 month ago
Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking a highly experienced Senior Manager of Drug Safety & Pharmacovigilance to join our Quality Assurance team.
Job Summary:The Senior Manager of Drug Safety & Pharmacovigilance will be responsible for overseeing the quality, compliance, and alliance management activities of our Drug Safety & Pharmacovigilance team. This role will lead the preparation, delivery, and response to GVP inspections, work closely with PV and QA teams to ensure patient safety, and monitor quality and compliance.
Key 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 and commercial activities 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
- Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activities
- 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
- Degree in pharmacy, life sciences, or a related field
- Minimum of 8 years of experience in pharmacovigilance or drug safety, with 8-10 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 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
- Proficiency in using pharmacovigilance databases and software
- Travel 30%
Arrowhead Pharmaceuticals, Inc. offers a competitive salary and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy
