Job details

Manager, IRT Triage

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.

Job Responsibilities

Manages assigned staff to assure compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with Operating agreements with co-marketing partners to meet assigned timeframes and to assure consistency of case records and documentation.
Designs and conducts quality reviews to verify the accuracy, completeness and validity of information for adverse event reports for the assigned product area.
Responsible for evaluating, tracking, documenting and processing adverse event reports received for assigned products, including the timely review and distribution to co-marketing partners and Eisai affiliate offices.
Evaluates the need for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and co-marketing partner Safety offices, healthcare professionals and consumers to obtain and follow-up reports of possible adverse events for assigned product area.
Interfaces with other Eisai Departments and affiliates for dissemination of Drug Safety information, including preparation and implementation of standard operating procedures, and standardization of coding practices among international offices.

Essential Functions

Accurate and timely triage of IRT Follow-ups into their correct workflow within LifeSphere. Identify cases that would meet criteria for new ICSR occurrence. Full understanding of the products’ Company Core Data sheet/IB, PI, and Always Serious List.
Interact with health professionals, consumers, and/or clinical investigators and their staff to obtain adverse event information as needed. Ensure any follow-up requested is accurate with thorough communication documented within the case.
Assist in projects requiring review and assessment of medical information obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests.
Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP/s, SWP/s and WID’s.
Supervision and management of assigned contractors to ensure timely and accurate coding of reports using appropriate conventions. Monitor time and attendance. Daily oversight of performance and remediation as indicated.

Requirements

Bachelor’s degree in medical field
Minimum 5-7 years of experience in and industry application of clinical medicine/pharmacy, including a minimum of 3 years of experience in International Product Safety
Knowledge of International and US Regulations of reporting Adverse Events for Investigational and Marketed products
Application of clinical medicine to patient care
Knowledge of medical terminology and standards of patient care
Excellent communication and organizational skills
Proven ability to work well with others.

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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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