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

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

Director, PSPV Compliant, Standards, and Training: Strategic leader responsible for the development and execution of PSPV compliance programs, processes, and training for in-development and marketed products.

This is a highly cross functional role. Typically works in close collaboration with all sub functions within PSPV, QA, Clinical, Legal, Commercial, Medical Affairs and other R&D areas.

Preferred 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 Skills, Qualifications and Technical Proficiencies:

• 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

Preferred Education and Experience:

• Bachelor's degree in healthcare or life sciences- An advanced degree such as RN or BSN, PharmD is preferred
• Minimum of 10 years Patient Safety/PV of experience with 5+ years of related experience in pharmacovigilance compliance, standards and training is required
• Strong experience in both safety operations and safety sciences is preferred
• Deep knowledge in FDA, EU and ICH guidelines is required
• Experience with NDA filing and product launch is preferred
• People management experience is preferred

The pay range that the Company reasonably expects to pay for this position is $194,700 - $250,000; 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.

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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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