Patient Safety & Pharmacovigilance Case Management Operations Lead

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.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

The Patient Safety & Pharmacovigilance (PSPV) Case Management Operations Lead provides strategic and operational oversight for global clinical and post-marketing safety operations across the product lifecycle. This role is responsible for the oversight, development, and continuous improvement of pharmacovigilance systems, processes, vendors, and teams to ensure compliance with global regulatory requirements and industry best practices.

Responsibilities:

Strategic Leadership & Organizational Management

Provide strategic leadership and direction for global Patient Safety and Pharmacovigilance Operations supporting clinical development and post-marketing programsDefine and execute the global safety operations strategy, operating model, and roadmap to support organizational growth and regulatory complianceBuild, lead, mentor, and develop high-performing safety operations teams, fostering a culture of accountability, quality, compliance and continuous improvementServe as a subject matter expert on pharmacovigilance operations, case management and regulatory reportingEstablish departmental objectives, resource strategies, budgets, KPIs, and operational metrics aligned with corporate priorities

Global Pharmacovigilance Operations

Provide strategic oversight of global Individual Case Safety Report (ICSR) management and expedited reporting activities across clinical development and post-marketing programsEnsure timely and compliant submission of adverse event reports to global regulatory authorities, ethics committees and investigatorsEnsure consistent implementation of global safety reporting requirements, safety management plans and case processing proceduresDirect operational support activities for aggregate safety reports, including DSURs, PADERs, PSURs, PBRERs, IND Annual Reports and other required regulatory submissions

Vendor Governance & Strategic Partnerships

Provide oversight of pharmacovigilance vendors, CROs, and strategic service providersEstablish governance frameworks, service level agreements (SLAs), KPIs, and quality metrics to ensure operational excellence and regulatory complianceOversee vendor performance, budgets, contracts, issue resolution, and continuous improvement initiativesEnsure vendor compliance with Safety Management Plans, Safety Data Exchange Agreements (SDEAs), and applicable global regulations

Compliance, Inspection Readiness & Quality Oversight

Ensure global pharmacovigilance operations remain inspection-ready and compliant with FDA, EMA, MHRA, PMDA, Health Canada, ICH, and other applicable global regulationsServe as the functional lead for Patient Safety Operations during regulatory inspections and auditsDrive implementation and maintenance of functional SOPs, work instructions, policies and other quality documentsDrive continuous improvement initiatives to strengthen compliance, quality, and operational performance

Safety Systems & Technology:

Serve as the business process owner or backup for the global safety database, ensuring the system supports compliant end-to-end case processing and reportingPartner with Safety Systems and Technology teams to optimize system configurations, reporting rules, workflows, and data standardsCollaborate with technology and business stakeholders to evaluate and implement innovative solutions that enhance scalability and operational effectiveness

Cross-Functional Leadership

Collaborate effectively with Clinical Development, Medical Affairs, Commercial, Biometrics, Data Management, Regulatory Affairs, Legal and Quality Assurance organizationsProvide strategic input and operational expertise during product development planning, regulatory submissions and commercialization activitiesLead cross-functional initiatives to improve operational efficiency, scalability, compliance and patient safety outcomes

Preferred Skills, Qualifications and Technical Proficiencies:

In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)Demonstrated leadership experience building and leading global pharmacovigilance operations within a biotechnology or pharmaceutical environmentProven ability to influence senior leadership and collaborate effectively with peer functional leaders across the organizationStrong expertise in safety database systems (e.g., Argus) and electronic reporting requirements, including demonstrated success with drug safety case processing combined with a thorough knowledge of drug safety database utilization, systems and applicationsExperience leading regulatory inspections, audits, vendor governance, and quality management initiativesStrong strategic, organizational, and operational leadership skills with a demonstrated ability to drive transformational change and continuous improvementExcellent communication, stakeholder management, and decision-making skills in a complex global environment

Preferred Education and Experience:

Degree in Healthcare (e.g., Pharmacy, Nursing, MD or a related field), advanced degree preferredMinimum of 12+ years of progressive experience in pharmacovigilance/patient safety within the biopharmaceutical industry, including at least 5 years in a leadership roleDemonstrated success leading global pharmacovigilance operations supporting both clinical development and post-marketing programsStrong track record of driving operational excellence, process optimization, organizational transformation, and continuous improvement initiativesDemonstrated experience establishing and managing strategic partnerships with CROs, pharmacovigilance vendors, and service providersExperience leading regulatory inspections, audits, and inspection readiness activities with global health authorities (e.g., FDA, EMA, MHRA, PMDA)

The pay range that the Company reasonably expects to pay for this position is $209,100 - $340,000; 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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

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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