Director, Pharmacovigilance Operations and Engagement

1w1 week ago

Corcept Therapeutics

Redwood City, US · Full-time · $240,000 – $280,000

About this role

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. The commercial portfolio includes treatments for hypercortisolism and oncology, with over 1,000 proprietary selective cortisol modulators discovered. Advanced clinical trials target hypercortisolism, solid tumors, ALS, and liver disease.

This role serves as the PSPV lead for cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout. It acts as a strategic partner to Medical Affairs, Quality, Legal, and Commercial teams, driving operational and compliance excellence. This is a hybrid role typically requiring on-site presence at least 3 days per week at headquarters.

Day-to-day involves building strategic partnerships with internal stakeholders and external vendors for patient safety objectives. Lead cross-functional governance forums to review commercial initiatives for planning and execution. Oversee safety lead responsibilities for call centers, specialty pharmacies, patient support programs, and distributors.

Collaborate closely with Medical Affairs to integrate key safety messages into scientific communications. Monitor compliance KPIs, support audit readiness as PSPV SME for commercial programs. Identify process improvements and stay current with evolving global PV regulations.

Join a team unlocking cortisol modulation to address devastating diseases. Highly visible role fosters operational excellence across all touchpoints. Headquartered in Redwood City, California, with more at www.corcept.com.

Requirements

Deep knowledge of pharmacovigilance regulations and global reporting timelines
Experience as PSPV lead in cross-functional commercial initiatives and product lifecycle management
Expertise in safety oversight for call centers, specialty pharmacies, patient support programs, and distributors
Proven ability to review vendor agreements for safety reporting requirements
Skills in developing adverse event reporting training and quality controls for safety data
Familiarity with reconciliation processes between vendors and internal PV systems
Competence in audit and inspection readiness as PV SME for commercial activities
Understanding of integrating safety messages into scientific communications

Responsibilities

Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders and external vendors/partners
Establish and lead cross-functional governance forum with PSPV, Medical Affairs, Quality, Legal, Commercial to review commercial initiatives
Act as Safety Lead for implementation and oversight of call center and commercial programs including specialty pharmacies and patient support
Review vendor agreements and program materials to ensure inclusion of safety-related reporting requirements
Ensure appropriate systems and processes for reporting safety information in compliance with global timelines
Develop and coordinate adverse event reporting training and oversee reconciliation processes for safety data accuracy
Contribute to review of deviations and CAPAs for commercial programs and monitor compliance KPIs
Identify opportunities for process improvements and technology solutions to enhance PV systems and workflows