Arrowhead Pharmaceuticals, Inc. San Diego , CA 92140
Posted 1 month ago
The Position
The Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with PV and QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting and CAPA development, monitor quality and compliance. The successful candidate will provide strategic direction, manage a team of quality assurance professionals, and collaborate with cross-functional teams to enhance the safety and quality of pharmaceutical products.
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
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
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
Requirements:
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%
Preferred:
Arrowhead Pharmaceuticals, Inc.