Director, Pharmacovigilance Operations and Engagement

Role Summary

Director, Pharmacovigilance Operations and Engagement will serve as the PSPV lead for cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout the organization. The role acts as a strategic partner to Medical Affairs, Quality, Legal and Commercial teams, driving operational and compliance excellence across all touchpoints. This is a hybrid role requiring on-site presence at least 3 days per week at the company headquarters in Redwood City.

Responsibilities

• Cross-Functional Leadership & Collaboration
  • 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
  • Act as the Safety Lead for implementation and oversight of call center and commercial programs (e.g., specialty pharmacies, patient support programs, market research, distributors, etc.) including:
    • Reviewing vendor agreements and program materials to ensure inclusion of safety-related reporting requirements and deliverables
    • Ensuring appropriate systems and processes are in place for reporting safety information to Corcept in compliance with binding obligations and global reporting timelines
    • Developing and coordinating adverse event reporting training
    • Overseeing reconciliation processes between vendors and internal PV systems to ensure completeness and accuracy of safety data
    • Ensuring appropriate quality controls are in place for the call center and commercial programs, including source data verification and quality sampling of safety data
    • Maintaining 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
• Compliance & Quality Oversight
  • 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
• Strategic Planning & Process Optimization
  • 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

Qualifications

• Ability to work in a dynamic environment to meet patient and corporate needs
• Deep knowledge of global PV regulations (ICH, GVP, FDA, EMA)
• Proven ability to lead cross-functional teams and influence commercial strategies
• Ability to manage multiple projects in a fast-paced environment
• Excellent communication (written and verbal) and stakeholder management skills
• Proficiency in safety database systems (e.g., Argus) and electronic reporting requirements

Education

• Degree in Healthcare or Life Sciences; advanced degree preferred
• 10+ years in pharmacovigilance biopharma
• 5+ years in leadership roles with cross-functional and commercial exposure
• Experience with vendor management and regulatory inspections

Additional Requirements

• Travel up to 10% of time