The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance.

Key Responsibilities

• Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements
• Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
• Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial and refresher training as well as monitoring of training completion and related compliance metrics/key performance indicators (KPIs)
• Contribute to and manage activities for the development, compilation and reporting of PV compliance metrics and KPI activities, including assessment of performance trends, compliance status, and identification of potential areas for improvement
• Support PSPV inspection readiness activities, including preparation of documentation, participation in mock inspections, and support of regulatory inspections
• Manage deviation, CAPA, and change control activities related to PSPV processes, including investigation support, documentation, and effectiveness checks
• Monitor changes in pharmacovigilance regulations and guidelines and support implementation of required procedural or training updates
• Support activities for the review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), including coordination of routine reviews and contribution updates across functions and vendors

Required Skills and Qualifications

• Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
• Strong working knowledge of pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with Quality Management Systems (e.g., Veeva or similar systems) are a plus
• Strong organizational, documentation, and attention-to-detail skills
• Effective written and verbal communication skills with the ability to collaborate across functions and with external vendors

Education and Experience

• Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
• Minimum of 5 years of experience in Patient Safety/PV with 2+ years of related experience in PV compliance, standards, training, or quality system activities
• Experienced in managing quality events (deviations, CAPAs, change controls)
• Inspection/audit support experience and project management skills preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,000 – $200,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

This 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. This highly visible role will act 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 typically requiring on-site presence at least 3 days per week at 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

Preferred Skills, Qualifications and Technical Proficiencies:

• 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
• Able to travel for up to 10% of time

Preferred Education and Experience:

• 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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000- $280,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.