Director, Pharmacovigilance Operations and Engagement
About The Position
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. 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.
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
- 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
- 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
- Applicants must be currently authorized to work in the United States on a full-time basis.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
251-500 employees
