Senior Director, Patient Safety & Pharmacovigilance Science

Safety Documentation & Reporting:

• Create and maintain product core safety information, including risk management plans (RMPs) and company core data sheets (CCDSs)
• Lead the preparation and development of global periodic aggregate safety reports
• Contribute to and review safety sections of clinical documents, including Investigator’s brochure (IB), clinical study protocols, and clinical study reports

Cross-Functional Collaboration:

• Facilitate cross-functional safety governance activities to ensure alignment of safety strategy and decision-making
• Establish and maintain collaborative relationships with senior stakeholders across functions to support the development and execution of product safety strategies

Regulatory & External Engagement:

• Work closely with safety physicians and cross-functional stakeholders to present safety data and provide expertise during key meetings (e.g., 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.

Inspection Readiness:

• Serve as a subject matter expert (SME) for relevant PSPV Science processes

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
• In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
• Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet self-motivated and timeline driven

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 epidemiology or public health is beneficial but not required
• 8+ years in patient safety and pharmacovigilance in the capacity of a scientist with a focus in the post-approval setting; at least 4 years of clinical development experience is required
• Related experience should include 2 or more years of supervisory/management experience in a matrix and geographically dispersed pharmaceutical/biotechnology organization
• Authoring and review of periodic and ad hoc safety reports (more than 5 years of experience required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
• Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation, interpretation, and relevance
• Experience in writing safety analysis, performing signal detection or safety surveillance, risk management and preparing responses to HA
• Working knowledge of industry standard pharmacovigilance data systems (e.g., Oracle Argus, data analytics, and signal management tools)
• Experience with NDA or MAA filing
• Endocrinology experience a plus

The pay range that the Company reasonably expects to pay for this position is $238,400 – $315,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.