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Associate Director, Patient Safety & Pharmacovigilance Science

Corcept Therapeutics

Role: Senior safety scientist responsible for monitoring and analyzing safety data of Corcept's investigational and marketed products, primarily in hypercortisolism, oncology, ALS, and liver disease. Responsibilities include performing safety data analyses, signal detection, risk management, developing safety documentation (RMPs, REMS), authoring safety reports (e.g., ISS, PBRERs), supporting regulatory submissions, and collaborating with cross-functional teams on safety governance and benefit-risk assessments. The role involves working closely with safety physicians, preparing safety content for regulatory agencies, and mentoring junior team members. Requirements: BS/BA in a related field with 4+ years of pharmacovigilance experience, including signal detection, safety surveillance, risk management, and safety reporting; Experience with pharmacovigilance systems like Argus; Knowledge of global PV regulations (ICH, GVP, FDA, EMA); Strong communication skills. Preferred: PhD, PharmD, or advanced degree; 2+ years of clinical development experience; Familiarity with NDA/MAA filing; Epidemiology/public health background beneficial. Location: The position is headquarters-based in Redwood City, California, with a focus on safety monitoring in a dynamic environment. #J-18808-Ljbffr Corcept Therapeutics

Vacancy posted 14 hours ago
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