Director, Pharmacovigilance Operations and Engagement

Описание вакансии

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

This will serve 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. This highly visible role will act as a strategic partner to Medical Affairs, Quality, Legal, and Commercial teams, driving operational and compliance excellence across all touchpoints. This is a hybrid role typically requiring on-site presence at least 3 days per week at company headquarters in Redwood City.

Responsibilities:

Cross-Functional Leadership & Collaboration:

• Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors/partners
• Establish and lead 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 agreements 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 binding 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

+ Collaborate 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.

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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