Director, Pharmacovigilance Operations and Engagement

Director, Pharmacovigilance Operations and Engagement

Location : Redwood City, California, United States

Corcept is a leader in the research and development of cortisol modulators. We discovered over 1,000 selective proprietary cortisol modulators and received FDA approval of Korlym (mifepristone) in 2012. We continue to conduct more than 30 ongoing studies across endocrinology, oncology, metabolism, and neurology, dedicated to advancing the possibilities of cortisol modulation.

This hybrid role requires on-site presence at least three days per week at Redwood City headquarters and serves 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.

Responsibilities

Cross-Functional Leadership & Collaboration :

Build strategic partnerships and align patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors / partners.

Establish and lead a 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 contracts 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 contractual 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.

Collaborating 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.

Corcept is an Equal Opportunity Employer.

J-18808-Ljbffr