Senior Director, Patient Safety & Pharmacovigilance Science

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. com . The Sr Director, Patient Safety PV Science will report to the Head of Safety Science and is responsible for safety monitoring of assigned Corcept products (investigational and marketed), with core safety deliverables related to safety governance, signal detection/management, and periodic and aggregate reporting.

This role demonstrates a high level of strategic thinking and may take on a SME role for one or more PSPV process. The Sr Director collaborates with PSPV team members to manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross-functionally to execute on the corporate development strategy.

Responsibilities

, Health Authorities, Data Safety Monitoring Boards, Investigators) Lead/contribute to health authority or other safety related query responses for Corcept products Leadership Team Development: Coach and mentor team members in applying safety expertise across Corcept product development and lifecycle activities Oversee PV vendor performance and drive continuous process improvement.

Qualifications

and Technical Proficiencies: Ability to work in a dynamic environment to meet corporate and patient needs Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries Excellent presentation, communication, and collaboration skills In-depth knowledge of global PV regulations and guide