Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)

Arrowhead Pharmaceuticals•San Diego, CA

29d

About The Position

The Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, 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 Drug Safety & Pharmacovigilance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with 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 PV Quality & Compliance professionals as applicable, and collaborate with cross-functional teams to enhance the safety and quality of pharmaceutical products.

Requirements

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.

Nice To Haves

Advanced degree in pharmacy, life sciences, or a related field

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.