Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
Under the guidance of the Senior Manager, Clinical Safety Data Review in the Oncology Business Group, the Medical Data Scientist 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 Senior Manager or above for resolution. Collaborates with Project Data Manager for timelines and with Data Operations to ensure the tracking /auto-generated 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’s 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).
- Advanced health care degree, Master’s 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).
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaults
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Location/Region: Westwood, NJ (07675)