Position Reports to: Chief Medical Officer
Provide leadership and medical oversight of global safety and pharmacovigilance activities for Syndax clinical trials, NCI trials and ISTs.
Provide guidance for the development of Syndax pharmacovigilance strategies.
Establish and maintain policies and procedures to support Clinical Drug Safety objectives.
Perform the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
Ensure ongoing evaluation of the overall safety profile of Syndax product. As product safety expert, collaborate with colleagues to bring potential safety issues to the attention of the Development Team and upper management.
Support Clinical Operations related to safety issues as required.
Provide input and review of responses to regulatory agency questions with regard to safety / pharmacovigilance activities.
Prepare and / or review safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.
Oversee the activities of both internal safety meetings (i.e. Pharmacovigilance Committee meetings) and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings).
Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
Support development and maintenance of product benefit-risk profile.
(Skills, Knowledge, Education and Work Experience)
M.D. degree and clinical experience, and at least 7 years of experience in Safety / Pharmacovigilance globally, including 2 3 years of experience in oncology required.
Working knowledge of FDA, EU, ICH guidelines and regulations governing Safety reporting and processing in clinical trial environments.
Working knowledge relevant to SAE analysis and SAE coding.
Proficient with Microsoft Windows: Word, Excel, Power Point.
Familiar with common Safety databases (e.g., Aris, AERS, Argus, etc.).
Excellent organizational, management, teamwork and interpersonal skills; prefers collaboration.
Able to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
Outstanding written and verbal communication skills.
Demonstrated skills in managing multiple projects.