Senior Director, Patient Safety & PV Science

Role Summary

The Senior 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 processes. The role collaborates with PSPV team members to manage key safety surveillance activities, safety analyses, risk management and safety document deliverables, and engages cross-functionally to support the corporate development strategy. This is a hybrid role, typically on-site three days/week in Redwood City, CA.

Responsibilities

• Safety Data Analysis & Signal Detection: Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings to monitor and define the safety profile for Corcept products
• Safety Data Analysis & Signal Detection: Lead proactive safety data reviews and analyses using data sources such as case series reviews, data summaries and AE trend evaluations
• Safety Data Analysis & Signal Detection: Collaborate with safety physicians on signal detection and risk management activities
• Safety Data Analysis & Signal Detection: Review medical and scientific literature to support signal detection and aggregate reporting
• Safety Data Analysis & Signal Detection: Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring in-depth safety analysis for consistent presentation across regulatory documents

• Safety Documentation & Reporting: Create and maintain product core safety information, including risk management plans (RMPs) and company core data sheets (CCDSs)
• Safety Documentation & Reporting: Lead the preparation and development of global periodic aggregate safety reports
• Safety Documentation & Reporting: Contribute to and review safety sections of clinical documents, including IBs, study protocols, and clinical study reports

• Cross-Functional Collaboration: Facilitate cross-functional safety governance activities to align safety strategy and decision-making
• Cross-Functional Collaboration: Establish and maintain collaborative relationships with senior stakeholders to support product safety strategies

• Regulatory & External Engagement: Present safety data and provide expertise during key meetings (Health Authorities, Data Safety Monitoring Boards, Investigators)
• Regulatory & External Engagement: Lead or contribute to health authority safety-related query responses for Corcept products

• Leadership & Team Development: Coach and mentor team members in applying safety expertise across product development and lifecycle activities
• Leadership & Team Development: Oversee PV vendor performance and drive continuous process improvement

• Inspection Readiness: Serve as a subject matter expert (SME) for PSPV Science processes

Qualifications

• Required: BS/BA degree in a related discipline; MD, PhD, PharmD or other advanced degree preferred
• Preferred: 8+ years in patient safety and pharmacovigilance in the post-approval setting, with at least 4 years of clinical development experience
• Preferred: 2+ years of supervisory/management experience in a matrix, geographically dispersed organization
• Preferred: Experience authoring and reviewing periodic and ad hoc safety reports (PSURs, DSURs, Clinical Overviews, CSRs or summaries) with more than 5 years in safety/clinical documents
• Preferred: Strong medical science analytical reasoning skills; proficient in data analysis software and data presentation
• Preferred: Experience with safety analysis, signal detection, risk management, and responses to health authorities
• Preferred: Working knowledge of pharmacovigilance data systems (e.g., Oracle Argus) and NDA/MAA filing experience

• Preferred: Ability to work in a dynamic environment to meet corporate and patient needs

Skills

• Excellent working knowledge of Argus (or similar applications), MS Office, electronic data capture systems, and MedDRA/WHO Drug dictionaries
• Excellent presentation, communication, and collaboration skills
• In-depth knowledge of global PV regulations and guidelines (ICH, GVP, FDA, EMA)
• Strong initiative; comfortable with ambiguity; self-motivated and timeline-driven

Education

• Preferred: MD, PhD, PharmD or other advanced degree in related discipline; BS/BA required
• Training or equivalent experience in epidemiology or public health is beneficial but not required