At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Under the guidance of the Sr Mgr, Clinical Safety Data Review - Oncology Business Group, performs review of Safety Data by reconciling the information from Safety report with Clinical Database. Ensures medically relevant information is captured in the Clinical database data entry fields. Generates Clinical Summaries for the subjects meeting the criteria of serious adverse events, adverse events that led to study discontinuation and clinically significant events determined by the study.
Responsibilities include but not limited to perform review of safety data within Clinical database by generating clinical summaries. Ensuring queries are posted and actioned within the expected timelines.
Discusses difficult cases and data discrepancies with Sr Mgr or above for resolution. Collaborates with Project Data Manager for timelines and with Data Operations to ensure the tracking /autogenerated template of Subjects meeting the criteria for review is accurate and in time for any milestone.
Write Clinical Summaries with quality, accuracy and relevant medical information. Observes the Eisai writing guidelines and study specific writing guidelines. Collaborate with other study teams across therapeutic areas on safety related matter especially SAE reconciliation. Consults with Study Directors to resolve safety data review issues/queries. Interface with Data Operations for System issues.
Perform review of safety data within Clinical database by reconciling safety report with data information in the clinical database.
Write Clinical Summaries with quality, accuracy and relevant medical information. Observe the Eisai writing guidelines and study specific writing guidelines
Ensuring queries are posted and actioned within the expected timelines
Participate in the development and implementation of department standards and documents as needed
Advanced health care degree, master degree in medical science, Nursing, Pharmacy or relevant biological science or healthcare field plus 3 years of experience in job offered.
Requires 2 years of medical/clinical data review ,
Use of I/J Review, Inform, and other tools collecting Clinical data and Word or Excel is a plus
Requires 2 years of experience supporting Oncology studies and reviewing data in Case Report Forms; managing CRO global team and supporting Oncology studies).
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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