Director, Pharmacovigilance Operations and Engagement at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

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

Responsibilities

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 contracts and program materials to ensure inclusion of safety-related reporting requirements and deliverables
Ensure appropriate systems and processes are in place for reporting safety information to Corcept in compliance with contractual obligations and global reporting timelines
Develop and coordinate adverse event reporting training
Oversee reconciliation processes between vendors and internal PV systems to ensure completeness and accuracy of safety data
Ensure appropriate quality controls are in place for the call center and commercial programs, including source data verification and quality sampling of safety data
Maintain 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
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
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

Skills

Key technologies and capabilities for this role

PharmacovigilancePSPVCross-Functional LeadershipPatient SafetyComplianceCommercial InitiativesGovernanceStrategic PartnershipsMedical AffairsQuality AssuranceRisk ManagementProduct LaunchLifecycle Management

Questions & Answers

Common questions about this position

Is this a remote role or does it require office presence?

This is a hybrid role typically requiring on-site presence at least 3 days per week at company headquarters in Redwood City.

What is the salary range for this position?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires expertise in pharmacovigilance operations, cross-functional leadership, compliance and quality oversight, vendor management, and strategic partnership building with teams like Medical Affairs, Quality, Legal, and Commercial.

What does the company culture or work environment look like?

This information is not specified in the job description.

What makes a strong candidate for this Director role?

Strong candidates will have proven leadership in pharmacovigilance (PSPV), experience establishing cross-functional governance, overseeing commercial safety programs like call centers and specialty pharmacies, ensuring compliance with safety reporting, and collaborating with Medical Affairs, Quality, Legal, and Commercial teams.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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