Safety Science Director

The Safety Science Director will report to the Sr. Medical Safety Director and is responsible for safety monitoring of assigned Corcept products (investigational and marketed), with core safety deliverables related to periodic and aggregate reporting.

Responsibilities:

• Should be passionate about working on cutting edge research and developing advanced analytics/informatics solutions in the field of safety analytics and surveillance
• Perform aggregate analysis and case level review of safety data, including data from clinical trials and post marketing.
• Conduct literature and PV database searches.
• Perform project management activities for safety reports/ deliverables.
• Work closely with safety physicians and liaise with cross-functional stakeholders and teams.
• Develop a product-specific Safety Plan. Perform safety data monitoring, analysis, and interpretation. Maintain good documentation. Communicate safety profile effectively (written and verbal) both internally and externally.
• Provide safety input to statistical analysis plans, and similar documents requiring significant safety analysis. Ensure consistent presentation of safety and risk management topics across various regulatory documents.
• When required, support safety physicians in authoring the safety sections of a regulatory package (for e.g., NDA, Briefing Document).
• Prepare and review aggregate safety reports including Periodic Adverse Drug Experience Reports (PADERs), development Safety Update Reports (DSURs), ISS, RMP, CCDS.
• Participate in safety / benefit-risk review meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings.
• Support PV vendor oversight, continuous process improvement, and inspections and audits.
• Provide scientific and technical leadership to support discovery and development project teams
• Maintain up to date knowledge related to technical area of expertise including areas of disease, drugs, data interpretation and integration, and regulatory and business environment

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 ICH guidelines
• Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet be self-motivated and timeline driven.

 Preferred Education and Experience:

• Registered Nurse, Pharmacist, or other degree in a Life Science-related field.
• Minimum 4-6 years safety and PV experience in the capacity of a scientist including a focus in post-approval setting, plus 2 years drug development experience. Other relevant experience may be considered.
• Authoring and review of periodic and ad hoc safety reports (more than 4 years of experienced required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
• Experience in writing safety analysis, performing signal detection or safety surveillance, risk management and preparing responses to HA.
• Experience with NDA filing is a plus.

The pay range that the Company reasonably expects to pay for this position is $234,100 - $275,400; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.