Associate Director, Patient Safety & Pharmacovigilance Science at Corcept Therapeutics in Redwood City, CA

Job 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 www.corcept.com . The Safety Science Associate Director 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, periodic and aggregate reporting. This role serves as an independent Safety Science contributor and collaborates with safety physicians and cross-functional stakeholders to support product development and lifecycle management activities. Responsibilities: Safety Data Analysis & Signal Detection: Perform safety data analyses using appropriate data sources, including case series reviews, data summaries and AE trend information Collaborate with safety physicians on signal detection and risk management activities. Perform safety data monitoring, analysis, and interpretation Review of medical and scientific literature for signal detection and aggregate reporting activities Safety Documentation & Reporting: Develop and maintain components of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents for assigned product(s) Prepare and review aggregate safety reports for assigned product(s) Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring safety analysis to ensure consistent presentation of safety and risk management topics for assigned product(s) Author and review safety reports and regulatory deliverables, including Integrated Summaries of Safety (ISS) and other submission-related documents Cross-Functional Collaboration: Participate in safety governance meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information and company core data sheets (CCDSs) Contribute to and review safety sections of clinical documents, including Investigator’s brochure (IB), clinical study protocols, and clinical study reports Regulatory & External Engagement: Work closely with safety physicians and cross-functional stakeholders in authoring the safety safety content for regulatory submissions and other key regulatory deliverables (e.g., NDA, Briefing Document) Prepare and review responses to health authority or other safety related query responses for assigned product(s) Leadership & Team Development: Mentor, train and collaborate with junior scientists on signal detection and risk management activities Support PV vendor oversight and continuous process improvement Preferred Skills, 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 Knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA) Preferred Education and Experience: PhD, PharmD or other advanced degree in related discipline is preferred. Other relevant experience may be considered without an advanced degree; BS/BA degree in related discipline is required. Training or equivalent experience in epide