Director, Pharmacovigilance Operations and Engagement

Corcept is a biopharmaceutical company leading the research and development of cortisol modulators. The Director of Pharmacovigilance Operations and Engagement will lead cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout the organization.

Requirements

• Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors/partners
• Establish and lead cross functional governance forum with PSPV, Medical Affairs, Quality, Legal, Commercial to review all commercial initiatives/activities for cross functional planning and execution
• Ensure appropriate systems and processes are in place for reporting safety information to Corcept in compliance with contractual obligations and global reporting timelines
• Develop and coordinate adverse event reporting training
• Maintain tracking of vendors/providers for the pharmacovigilance system master file
• Collaborate closely with Medical Affairs to integrate key safety messages into scientific communications and materials
• Contribute to review of deviations and CAPAs for commercial programs and call center
• Monitor and report compliance key performance indicators for commercial programs and call center to PSPV compliance lead
• Support audit and inspection readiness, including being the PSPV SME for commercial programs and call center activities
• Identify opportunities for process improvements and technology solutions to enhance PV systems and workflows
• Stay current with evolving global PV regulations and assess impact on organizational practices
• Support development of PV strategies aligned with corporate objectives and patient safety goals

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off