Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)

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 role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations by ensuring the quality, compliance, and timely reporting of safety information from company-sponsored clinical trials, Investigator-Initiated Studies, and expanded access/compassionate use programs.
Responsibilities:
Conduct quality review of clinical trial safety reports to ensure completeness and accuracy of safety data, consistency between source documentation, EDC and safety database records, and compliance with study-specific, internal and global regulatory requirements
Support review and reconciliation of safety data to ensure investigator/site-reported information is accurately reflected in EDC and safety database
Generate clinically relevant safety follow-up queries and collaborate with cross functional study teams and CRO to ensure timely resolution, escalating delays or missing information that impact case assessment, evaluation, or regulatory compliance
Review safety submission documentation, e.g., expedited and aggregate reports, to ensure accurate, complete and timely reporting in accordance with global regulatory requirements
Support oversight and monitoring activities of PV vendor(s) and provide feedback to support training and process improvement
Support study-level safety operations activities and other PSPV projects, as assigned
Assists in the creation/revision of department standard operating procedures and work instructions
Development and delivery of training for safety related topics
Support process improvement initiatives and safety systems activities
Support and participate in audits and inspections, including preparation activities
Preferred Skills, Qualifications and Technical Proficiencies:
Ability to work in a dynamic environment to meet patient and corporate needs
Knowledge of Argus (or similar safety applications) and EDC systems (e.g., Medidata RAVE)
Excellent communication and collaboration skills
Ability to manage multiple projects in a fast-paced environment
Able to travel for up to 10% of time
Preferred Education and Experience:
Bachelor's degree in healthcare or life sciences - degree such as RN or BSN, PharmD is preferred
3 years of PSPV operations experience within a pharmaceutical or biotechnology company
Candidates without prior PSPV experience will also be considered if they have at least 5 years of direct oncology clinical-study experience such as a Clinical Research Coordinator (CRC), Research Nurse, and/or Clinical Research Associate (CRA)
Working knowledge of FDA, EU and ICH guidelines for safety reporting for clinical trials
The pay range that the Company reasonably expects to pay for this headquarters-based position is $103,600 – $137,100; 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
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.