Assistant Medical Director, Product Safety at Eisai in Woodcliff Lake, New Jersey

Job Description:

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.

Assistant Medical Director, Product Safety

Job Summary:

The Assistant Medical Director provides medical expertise in the review and evaluation of safety information for Eisai investigational and marketed products. The incumbent will design and develop safety surveillance strategy for products' lifecycle and regulatory approvals, monitor and audit the company's safety surveillance program, and ensure the completeness and accuracy of medical information and safety assessment of individual and aggregated reports.

The Associate Medical Director will participates in the resolution of any legal liability and complying with governmental regulations. Provide trending and safety signal detection and risk management assessment for the products' life cycle, provides safety support to the clinical development and other teams and ensure accurate receipt, maintenance and assessment against efficacy and product indication.Create and provide clinical information and safety reports as required by regulatory agencies including adverse events data from clinical trials and/or consumer usage, spontaneous or solicited sources, periodic and experience reports. Support all clinical trial activity, post marketing safety surveillance, and adverse event collection and reporting, and a typical day would include:

• The evaluation of serious clinical trial adverse events and spontaneous reports of adverse events.


• Assess the relationship between drugs and adverse events.


• Determines case reportability per local regulatory requirements and meets appropriate timelines for reporting.


• Participates in the training of the Safety Specialist and Coordinators.

Essential Functions:

• Medical Review of Spontaneous and Clinical Trial SAE reports.


• Participates in the training of the Safety Specialists.


• Administration, Education and miscellaneous.

Requirements:

• MD degree-required, US Board Certified/eligible desirable


• Previous experience in pharmaceutical development or related industry is desirable


• Knowledge of disease pathology and physiology, pharmacology and therapeutics


• Ability to work effectively with cross functional departmental teams


• Strong organizational, written and verbal communication skills


• Strong computer proficiency skills

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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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