Senior Director, Patient Safety & Pharmacovigilance Science

Senior Director role overseeing patient safety and pharmacovigilance for Corcept's investigational and marketed products. Responsible for safety monitoring, signal detection, risk management, and regulatory reporting across clinical and post-marketing settings.

Responsibilities

• Develop and execute signal detection and risk management strategies for assigned products
• Lead proactive safety data reviews and trend analyses using multiple data sources
• Create and maintain product safety documentation including risk management plans and core data sheets
• Prepare global periodic aggregate safety reports and contribute to clinical study safety sections
• Facilitate cross-functional safety governance and collaborate with health authorities on safety matters

Requirements

• Advanced degree in life sciences, pharmacy, or related field with substantial pharmacovigilance experience
• Demonstrated expertise in safety signal detection and risk management strategies
• Experience developing and maintaining risk management plans and periodic safety reports
• Strong knowledge of regulatory requirements and health authority interactions
• Proficiency in safety data analysis and medical literature review
• Proven cross-functional collaboration and stakeholder management skills