Associate Medical Director, PV Operations - Eisai

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 Summary

Provides medical expertise in the review and evaluation of safety information for Eisai investigational and marketed products, including: evaluation of serious clinical trial adverse events and spontaneous reports of adverse events.

Essential Functions

• Medical Review of Spontaneous and Clinical Trial SAE reports
• Participates in the training of the Safety Specialists
• Administration, Education and miscellaneous
• 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.

Requirements

• MD degree-required, US Board Certified/eligible desirable
• 3 + years previous experience in pharmaceutical development or related industry, or product safety desirable
• Knowledge of disease pathology and physiology, pharmacology and therapeutics
• Ability to work effectively in cross-departmental teams
• Strong organizational, written and verbal communication skills
• Computer 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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