Patient Safety & Pharmacovigilance Case Management Operations Lead
Redwood City, California, United States · On-site
$209k–$340k/yr
Senior+$119M raised
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Skills: Pharmacovigilance, Case Management, Regulatory Compliance, Vendor Governance, Strategic Leadership
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Associate Director, Quality Systems Monitoring & Excellence
Redwood City, California, United States · Hybrid
$186k–$233k/yr
Senior+
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress dive…
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$209k–$340k/yr
Full-time
bachelor degree, postgraduate degree
Posted 6d ago
~40 hrs/week
Responsibilities
The role provides strategic and operational oversight for global pharmacovigilance systems, processes, and teams across the product lifecycle. It involves managing vendor performance, ensuring regulatory compliance, and leading cross-functional initiatives to improve safety operations.
Requirements
Candidates must have at least 12 years of experience in pharmacovigilance within the biopharmaceutical industry, including 5 years in a leadership role. A degree in a healthcare-related field is required, with an advanced degree preferred, alongside deep knowledge of global PV regulations and safety database systems.
Full job description
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 Patient Safety & Pharmacovigilance (PSPV) Case Management Operations Lead provides strategic and operational oversight for global clinical and post-marketing safety operations across the product lifecycle. This role is responsible for the oversight, development, and continuous improvement of pharmacovigilance systems, processes, vendors, and teams to ensure compliance with global regulatory requirements and industry best practices.
Responsibilities:
Strategic Leadership & Organizational Management
Provide strategic leadership and direction for global Patient Safety and Pharmacovigilance Operations supporting clinical development and post-marketing programs
Define and execute the global safety operations strategy, operating model, and roadmap to support organizational growth and regulatory compliance
Build, lead, mentor, and develop high-performing safety operations teams, fostering a culture of accountability, quality, compliance and continuous improvement
Serve as a subject matter expert on pharmacovigilance operations, case management and regulatory reporting
Establish departmental objectives, resource strategies, budgets, KPIs, and operational metrics aligned with corporate priorities
Global Pharmacovigilance Operations
Provide strategic oversight of global Individual Case Safety Report (ICSR) management and expedited reporting activities across clinical development and post-marketing programs
Ensure timely and compliant submission of adverse event reports to global regulatory authorities, ethics committees and investigators
Ensure consistent implementation of global safety reporting requirements, safety management plans and case processing procedures
Direct operational support activities for aggregate safety reports, including DSURs, PADERs, PSURs, PBRERs, IND Annual Reports and other required regulatory submissions
Vendor Governance & Strategic Partnerships
Provide oversight of pharmacovigilance vendors, CROs, and strategic service providers
Establish governance frameworks, service level agreements (SLAs), KPIs, and quality metrics to ensure operational excellence and regulatory compliance
Ensure global pharmacovigilance operations remain inspection-ready and compliant with FDA, EMA, MHRA, PMDA, Health Canada, ICH, and other applicable global regulations
Serve as the functional lead for Patient Safety Operations during regulatory inspections and audits
Drive implementation and maintenance of functional SOPs, work instructions, policies and other quality documents
Drive continuous improvement initiatives to strengthen compliance, quality, and operational performance
Safety Systems & Technology:
Serve as the business process owner or backup for the global safety database, ensuring the system supports compliant end-to-end case processing and reporting
Partner with Safety Systems and Technology teams to optimize system configurations, reporting rules, workflows, and data standards
Collaborate with technology and business stakeholders to evaluate and implement innovative solutions that enhance scalability and operational effectiveness
Cross-Functional Leadership
Collaborate effectively with Clinical Development, Medical Affairs, Commercial, Biometrics, Data Management, Regulatory Affairs, Legal and Quality Assurance organizations
Provide strategic input and operational expertise during product development planning, regulatory submissions and commercialization activities
Lead cross-functional initiatives to improve operational efficiency, scalability, compliance and patient safety outcomes
Preferred Skills, Qualifications and Technical Proficiencies:
In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
Demonstrated leadership experience building and leading global pharmacovigilance operations within a biotechnology or pharmaceutical environment
Proven ability to influence senior leadership and collaborate effectively with peer functional leaders across the organization
Strong expertise in safety database systems (e.g., Argus) and electronic reporting requirements, including demonstrated success with drug safety case processing combined with a thorough knowledge of drug safety database utilization, systems and applications
Experience leading regulatory inspections, audits, vendor governance, and quality management initiatives
Strong strategic, organizational, and operational leadership skills with a demonstrated ability to drive transformational change and continuous improvement
Excellent communication, stakeholder management, and decision-making skills in a complex global environment
Preferred Education and Experience:
Degree in Healthcare (e.g., Pharmacy, Nursing, MD or a related field), advanced degree preferred
Minimum of 12+ years of progressive experience in pharmacovigilance/patient safety within the biopharmaceutical industry, including at least 5 years in a leadership role
Demonstrated success leading global pharmacovigilance operations supporting both clinical development and post-marketing programs
Strong track record of driving operational excellence, process optimization, organizational transformation, and continuous improvement initiatives
Demonstrated experience establishing and managing strategic partnerships with CROs, pharmacovigilance vendors, and service providers
Experience leading regulatory inspections, audits, and inspection readiness activities with global health authorities (e.g., FDA, EMA, MHRA, PMDA)
The pay range that the Company reasonably expects to pay for this position is $209,100 - $340,000; 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.
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.
Pioneering the discovery and development of cortisol modulators.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Redwood City, California
LinkedIn followers
73,767
Total funding
$119M
We’ve been unlocking the potential of cortisol modulation for more than 25 years.
We’re 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 a groundbreaking cortisol receptor blocker and 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.
Offices: 101 Redwood Shores Pkwy, Redwood City, California 94065, US
How much do Management & Leadership jobs in Redwood City, CA pay?
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