Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 11 days ago

Associate Director, Patient Safety & Pharmacovigilance Compliance, Standards & Training

Corcept Therapeutics76 open roles

Pay
$183,500 – $242,800 a year
Where
Redwood City, California, United States
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowAssociate Director, Patient Safety & Pharmacovigilance Compliance, Standards & TrainingCorcept Therapeutics · Redwood City, California, United States

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Corcept Therapeutics's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market. Corcept Therapeutics postings stay open a median of 32 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 11 days ago

Corcept Therapeutics median: 32 days open

The 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.

Please visit our website at: https://www.corcept.com/

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.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Corcept Therapeutics's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Corcept Therapeutics's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Corcept Therapeutics's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.