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

Overview

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.

In Short

• Strategic leader responsible for PSPV compliance programs and training.
• Oversee the PSPV Quality Management System (QMS).
• Create and maintain PSPV procedures compliant with global regulations.
• Develop role-based pharmacovigilance training programs.
• Ensure compliance oversight of safety reports.
• Support implementation of new pharmacovigilance systems.
• Lead gap assessments and continuous improvement initiatives.
• Manage inspection readiness activities and CAPAs.
• Establish KPIs and KQIs for PV effectiveness.
• Facilitate readiness for new product launches.

Requirements

• Bachelor's degree in healthcare or life sciences; advanced degree preferred.
• 10+ years of Patient Safety/PV experience.
• 5+ years in pharmacovigilance compliance, standards, and training.
• Strong knowledge of FDA, EU, and ICH guidelines.
• Experience with NDA filing and product launch preferred.
• People management experience preferred.

Benefits

• Opportunity to work in a dynamic environment.
• Collaboration with cross-functional teams.
• Contribution to innovative healthcare solutions.
• Competitive salary and benefits package.