Patient SafetyPharmacovigilance CompliancePharmacovigilance Standards and Training
Required qualifications
Field of studyHealthcare, Life Sciences (or related)
Study levelBachelor's
Preferred qualifications
Field of studyLeadership, Management, scientific discipline
Study levelMaster's
Original posting
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 Associate Director, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training, is responsible for refining/ improving, maintaining, and executing the PSPV quality and compliance framework for in-development and marketed products. The role serves as an advisor for PSPV compliance, standards, and training matters and cross-functional leader across PSPV, Quality Assurance, Clinical, Legal, Commercial, Medical Affairs, and other R&D functions, providing risk-based recommendations, resolving complex issues, and escalating matters requiring Director-level decisions. The position leads significant cross-functional initiatives and provides leadership, coaching, and performance oversight for assigned staff and project teams. Additional responsibilities may be assigned based on organizational needs and business priorities.
Responsibilities:
Refine and maintain the PSPV Quality Management System (QMS)
Serve as a subject matter expert and advisor on PSPV compliance, standards, and training matters; provide risk-based recommendations to PSPV and cross-functional leaders and escalate matters with significant regulatory, patient safety, or business impact
Lead significant or complex PSPV investigations and quality issues, including governance of root cause analysis, corrective and preventive action (CAPA) plans, implementation, and effectiveness monitoring; ensure issues are appropriately documented and escalated
Lead and manage compliance monitoring activities, including evaluating trends and timely remediation
Lead complex, cross-functional programs within Compliance, Standards, and Training, including governance, risk management, decision-making, and communication of outcomes to senior stakeholders
Serve in a leadership during regulatory inspections and audits, including readiness planning, evidence strategy, interview preparation, response development, and remediation governance
Provide governance and oversight on the development, maintenance, and continuous improvement of processes for PSPV procedures and training materials
Assess the impact of changes to global pharmacovigilance requirements on PSPV processes, standards, systems, and training; recommend implementation strategies and direct assigned change activities
Lead assigned role-based PSPV training programs, including training strategy, curricula, onboarding, periodic training and retraining
Lead, coach, and develop assigned employees and project teams; set objectives, monitor performance, and build organizational capability and succession readiness within the function
Provide compliance oversight and risk-based governance of PSPV vendors and vendor-related quality issues
Provide compliance oversight of ICSR and aggregate reporting processes, including escalation of compliance risks
Lead continuous improvement of processes arising from gap assessments for PSPV procedures and training material; recommend priorities and governance actions; and oversee implementation of significant or cross-functional improvements
Provide governance and oversight of PSMF maintenance activities
Lead assigned PSPV launch-readiness activities
Assess impact on assigned systems and change activities
Act on behalf of the Director for assigned forums or initiatives, within delegated authority, and ensure decisions, risks, and matters requiring broader strategic direction are communicated and escalated appropriately
Preferred Skills, Qualifications and Technical Proficiencies:
Extensive knowledge of and demonstrated experience with Good Pharmacovigilance Practices (GVP)
Knowledge of and experience with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP) are highly desirable
Ability to work across geographic boundaries, with strong leadership skills and the ability to inspire colleagues
Sound judgment and decision-making skills
Ability to influence and motivate others without direct authority
Proven people-leadership and performance-management experience
Action- and results-oriented approach
Project management skills are preferred
Preferred Education and Experience:
Bachelor's degree in healthcare, life sciences, or a related discipline is required; a master's degree in management, leadership, or a scientific discipline is a plus
Minimum of 8 years of experience in the pharmaceutical industry with 3+ years of progressively responsible experience in pharmacovigilance compliance, standards, training, quality systems, or a closely related area
Experience in a leadership role during regulatory inspections or audits, including readiness planning, is required; experience with response development is preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,500 – $242,800; 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.
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.