Associate Director, Patient Safety & Pharmacovigilance Compliance, Standards & Training

About this role

Associate Director, Patient Safety & Pharmacovigilance Compliance, Standards & Training

Corcept Therapeutics

Portola Valley, CA, United States

Description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit

The Associate Director, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training, is responsible for refining/ improving, maintaining, and executing the PSPV quality and compliance framework for in-development and marketed products. The role serves as an advisor for PSPV compliance, standards, and training matters and cross-functional leader across PSPV, Quality Assurance, Clinical, Legal, Commercial, Medical Affairs, and other R&D functions, providing risk-based recommendations, resolving complex issues, and escalating matters requiring Director-level decisions. The position leads significant cross-functional initiatives and provides leadership, coaching, and performance oversight for assigned staff and project teams. Additional responsibilities may be assigned based on organizational needs and business priorities.

Responsibilities:

• Refine and maintain the PSPV Quality Management System (QMS)
• Serve as a subject matter expert and advisor on PSPV compliance, standards, and training matters; provide risk-based recommendations to PSPV and cross-functional leaders and escalate matters with significant regulatory, patient safety, or business impact
• Lead significant or complex PSPV investigations and quality issues, including governance of root cause analysis, corrective and preventive action (CAPA) plans, implementation, and effectiveness monitoring; ensure issues are appropriately documented and escalated
• Lead and manage compliance monitoring activities, including evaluating trends and timely remediation
• Lead complex, cross-functional programs within Compliance, Standards, and Training, including governance, risk management, decision-making, and communication of outcomes to senior stakeholders
• Serve in a leadership during regulatory inspections and audits, including readiness planning, evidence strategy, interview preparation, response development, and remediation governance
• Provide governance and oversight on the development, maintenance, and continuous improvement of processes for PSPV procedures and training materials
• Assess the impact of changes to global pharmacovigilance requirements on PSPV processes, standards, systems, and training; recommend implementation strategies and direct assigned change activities