New · posted Oct 31
Corcept Therapeutics · Pharmaceuticals
Associate Director, Patient Safety & Pharmacovigilance Compliance, Standards & Training
- Redwood City, CA
- On-site
- Full-time
- Director
The 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.
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.
What you need
Preferred Education and Experiencenice to have
- 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
Applicants must be currently authorized to work in the United States on a full-time basis.
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.
Preferred Skills, Qualifications and Technical Proficienciesnice to have
- 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
What you'll do
- 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
Pay
$183,500 – $242,800 a year
Employer providedThe 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.
Where you'll work
Redwood City, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Redwood City, CAEqual opportunity, accessibility and legal noticesCorcept Therapeutics's statements, word for word
Corcept is an Equal Opportunity Employer
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.
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in California19 roles publishing pay
Director roles in the US87 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $183,500 | — | $242,800 |
| California (middle half) | $234,000 | $264,000 | $294,500 |
| All US (middle half) | $221,250 | $263,500 | $279,250 |
This role: Corcept Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 161 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Corcept Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership19
- GMP and compliance10
- Quality systems and risk5
- Documentation and SOPs3
- Clinical trial conduct2
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Corcept Therapeutics on Regulatory Jobs
- 22
- Open roles
- 22
- Distinct roles
- 1
- Locations
By discipline
- Clinical17 77%
- Regulatory3 14%
- Quality2 9%
By level
- Director10 45%
- Senior & Principal5 23%
- Manager4 18%
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Associate Director, Patient Safety & Pharmacovigilance Compliance, Standards & Training at Corcept Therapeutics
Open until filled. $184K–$243K a year, employer provided.