Senior Director, Patient Safety & Pharmacovigilance Science

Role: Senior Director of Patient Safety & PV Science, overseeing safety monitoring and signal detection for Corcept's investigational and marketed therapies. Responsibilities include developing safety strategies, conducting proactive data reviews, managing safety documentation (e.g., RMPs, PSURs), and ensuring regulatory compliance. The role involves cross-functional collaboration with safety physicians, clinical teams, and external regulatory bodies, as well as leading safety governance and inspection readiness. Qualifications: PhD, PharmD, or related advanced degree preferred; 8+ years in pharmacovigilance or patient safety, with at least 4 years in clinical development. Experience in safety data analysis, signal detection, risk management, and safety reporting (PSURs, DSURs) is required, along with proficiency in data analysis tools (e.g., Argus) and knowledge of global PV regulations (ICH, GVP, FDA, EMA). Preferred expertise includes endocrinology, NDA/MAA submissions, and supervisory experience in a matrixed biotech/pharma environment. The position reports to the Head of Safety Science and involves strategic leadership, team mentorship, and stakeholder engagement. Location details and travel expectations are not specified.