The Safety Science Associate Director will report to the Head of Safety Science and is responsible for safety monitoring of assigned Corcept products (investigational and marketed), with core safety deliverables related to safety governance, signal detection/management, periodic and aggregate reporting. This role serves as an independent Safety Science contributor and collaborates with safety physicians and cross-functional stakeholders to support product development and lifecycle management activities.
Responsibilities:Safety Data Analysis & Signal Detection:
- Perform safety data analyses using appropriate data sources, including case series reviews, data summaries and AE trend information
- Collaborate with safety physicians on signal detection and risk management activities. Perform safety data monitoring, analysis, and interpretation
- Review of medical and scientific literature for signal detection and aggregate reporting activities
Safety Documentation & Reporting:
- Develop and maintain components of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents for assigned product(s)
- Prepare and review aggregate safety reports for assigned product(s)
- Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring safety analysis to ensure consistent presentation of safety and risk management topics for assigned product(s)
- Author and review safety reports and regulatory deliverables, including Integrated Summaries of Safety (ISS) and other submission-related documents
Cross-Functional Collaboration:
- Participate in safety governance meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information and company core data sheets (CCDSs)
- Contribute to and review safety sections of clinical documents, including Investigator's brochure (IB), clinical study protocols, and clinical study reports
Regulatory & External Engagement:
- Work closely with safety physicians and cross-functional stakeholders in authoring the safety safety content for regulatory submissions and other key regulatory deliverables (e.g., NDA, Briefing Document)
- Prepare and review responses to health authority or other safety related query responses for assigned product(s)
Leadership & Team Development:
- Mentor, train and collaborate with junior scientists on signal detection and risk management activities
- Support PV vendor oversight and continuous process improvement
Preferred Skills, Qualifications and Technical Proficiencies:- 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
- Excellent presentation, communication, and collaboration skills
- Knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
Preferred Education and Experience:- 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. Training or equivalent experience in epidemiology or public health is beneficial but not required
- 4+ years in experience in patient safety and pharmacovigilance in the capacity of a scientist, including experience in safety surveillance, signal detection and evaluation, aggregate reporting, and risk management activities. At least 2 years of clinical development experience is required
- Experience in writing safety analyses, performing signal detection or safety surveillance, risk management and preparing responses to HA
- Authoring and review of periodic and ad hoc safety reports and clinical development documents, including PSURs/PBRERs, DSURs, Clinical Overviews, Clinical Study Reports, Investigator's Brochures, or related documents
- Experience with industry standard pharmacovigilance data systems (e.g., Oracle Argus, data analytics, and signal management tools)
- Experience with NDA/MAA filing is beneficial but not required
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,500 - $269,800; 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.
