Director, Patient Safety & PV Compliance, Standards, and Training

Summary

Join Corcept Therapeutics as Director, PSPV Compliant, Standards, and Training, a strategic leadership role focused on developing and executing PSPV compliance programs, processes, and training for in-development and marketed products. This highly cross-functional role demands close collaboration with various departments, including QA, Clinical, Legal, Commercial, Medical Affairs, and R&D. The position requires ensuring operational excellence through oversight of the PSPV Quality Management System (QMS), maintaining regulatory compliance, developing training programs, and overseeing vendor compliance. Responsibilities also include safety report oversight, systems implementation, gap assessments, inspection readiness, KPI/KQI development, regulatory change monitoring, and global product launch support. The ideal candidate will possess strong knowledge of Argus or similar applications, excellent communication skills, and a minimum of 10 years of Patient Safety/PV experience, including 5+ years in pharmacovigilance compliance, standards, and training. A Bachelor's degree in healthcare or life sciences is required, with an advanced degree preferred.

Requirements

• Bachelor's degree in healthcare or life sciences
• Minimum of 10 years Patient Safety/PV of experience with 5+ years of related experience in pharmacovigilance compliance, standards and training is required
• Deep knowledge in FDA, EU and ICH guidelines is required

Responsibilities

• Ensure Operational Excellence: Oversee the PSPV Quality Management System (QMS), ensuring consistent, high-quality operational processes aligned with regulatory standards and business objectives
• Regulatory Compliance and Procedures: Create, revise, and maintain PSPV procedures and processes, ensuring they are compliant with global regulatory requirements (FDA, EMA, ICH, etc.)
• Training and Development: Develop and implement role-based pharmacovigilance (PV) training programs, ensuring that personnel are well-equipped to meet compliance requirements and operational standards
• Vendor Oversight: Create and maintain vendor-specific processes and training plans to ensure external partners comply with the company’s DSPV PSPV standards and regulatory requirements
• Safety Report Oversight: Ensure compliance oversight of Individual Case Safety Reports (ICSRs) and aggregate safety reports (PBRERs, PSURs) to be submitted to global regulatory bodies
• Systems Implementation and Updates: Support the implementation of new pharmacovigilance systems and manage the creation and update of associated processes and training materials to maintain system functionality and compliance
• Gap Assessment and Continuous Improvement: Regularly perform gap assessments of the PSPV QMS and lead the implementation of improvements by collaborating with cross-functional teams to address identified areas for improvement
• Inspection Readiness and CAPA: Lead DSPV PSPV planning for inspection readiness activities, ensuring the organization is always prepared for regulatory inspections. Manage Corrective and Preventive Actions (CAPAs) as necessary
• KPI/KQI Development and Oversight: Establish robust Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) to assess the effectiveness of the PV Provide regular monitoring and reporting of these metrics to leadership
• Regulatory Change Monitoring and Implementation: Monitor changes to pharmacovigilance regulatory requirements globally and lead the implementation of necessary process updates to ensure ongoing compliance with regulatory standards
• Global Product Launch Support: Facilitate readiness activities for new product launches across all PSPV functions, ensuring that safety monitoring and regulatory reporting are in place from day one of product commercialization

Preferred Qualifications

• Ability to work in a dynamic environment to meet patient and corporate needs
• Strong knowledge of Argus (similar applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
• Excellent communication and collaboration skills
• Demonstrated success in taking the initiative in a team. Comfortable with ambiguity yet be self-motivated and timeline driven
• An advanced degree such as RN or BSN, PharmD is preferred
• Strong experience in both safety operations and safety sciences is preferred
• Experience with NDA filing and product launch is preferred
• People management experience is preferred