Corcept Therapeutics
Senior Director, Patient Safety & Pharmacovigilance Science
Redwood City, California, United States · Director
Sponsorship not specified$238k-$316kDetected 1 day ago
Data AnalysisStatisticsClinical TrialsPublic HealthFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationMicrosoft OfficeEpidemiology
About the role
- 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.
Responsibilities
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings to monitor and define the safety profile for Corcept products
- Lead proactive safety data reviews and analyses using appropriate data sources, including case series reviews, data summaries and/or AE trend evaluations
- Collaborate with safety physicians on signal detection and risk management activities
- Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring in-depth safety analysis to ensure consistent presentation of safety and risk management topics across regulatory documents
- Create and maintain product core safety information, including risk management plans (RMPs) and company core data sheets (CCDSs)
- Lead the preparation and development of global periodic aggregate safety reports
- Contribute to and review safety sections of clinical documents, including Investigator's brochure (IB), clinical study protocols, and clinical study reports
- Establish and maintain collaborative relationships with senior stakeholders across functions to support the development and execution of product safety strategies
- Oversee PV vendor performance and drive continuous process improvement.
Requirements
- Ability to work in a dynamic environment to meet corporate and patient needs
- Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
- In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
- 8+ years in patient safety and pharmacovigilance in the capacity of a scientist with a focus in the post-approval setting
- at least 4 years of clinical development experience is required
- PhD, PharmD or other advanced degree in related discipline is preferred.
- Other relevant experience may be considered without an advanced degree; BS/BA degree in related discipline is required.
- 8+ years in patient safety and pharmacovigilance in the capacity of a scientist with a focus in the post-approval setting; at least 4 years of clinical development experience is required
- Authoring and review of periodic and ad hoc safety reports (more than 5 years of experience required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
- Experience with NDA or MAA filing
- Excellent presentation, communication, and collaboration skills
- Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet self-motivated and timeline driven
Nice to have
- Preferred Skills, Qualifications and Technical Proficiencies:
Skills
- https://www.corcept.com/
- Corcept is an Equal Opportunity Employer
Compensation
- The pay range that the Company reasonably expects to pay for this position is $238,400 – $315,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experie
Benefits
- Work closely with safety physicians and cross-functional stakeholders to present safety data and provide expertise during key meetings (e.g., Health Authorities, Data Safety Monitoring Boards, Investigators)
- Lead/contribute to health authority or other safety related query responses for Corcept products
- Training or equivalent experience in epidemiology or public health is beneficial but not required
- Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation, interpretation, and relevance
- Review of medical and scientific literature to support signal detection and aggregate reporting
- Preferred Education and Experience:
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