Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)
Corcept Therapeutics
Summary
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.
Job description
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
Requirements
- Bachelor's degree in healthcare or life sciences
- 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
- 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
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.