Manager, Product Safety - 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

• 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.
• Responsible for evaluating, tracking, documenting and processing adverse event reports received for assigned product, 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 the assigned product area.
• Provides product information to health care professionals, consumers, sales representatives, and other Safety staff for all marketed and investigational Eisai products
• Designs and conducts quality reviews to verify the accuracy, completeness and validity of information for adverse event reports for the assigned product area, codes and enters information into the global safety database as required
• Creates and reviews individual and summary reports for submission to the FDA and International Regulatory authorities.
• Interface with other Eisai  Departments and affiliates for dissemination of Drug Safety information, including training and orientation programs for Sales and Marketing, preparation and implementation of standard operating procedures, standardization of coding practices among International offices.
• Interface with Clinical for investigator training

Essential Functions

• Adverse event information collection, processing, tracking and distribution; Interact with health professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE’s from clinical trials. 30%
• 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. 20%
• Set standards for data collection and distribution processes; coordinates with direct reports to assure policies are implemented. Assures regulatory and internal timeframes for the processing of adverse event information are met. Reviews data to verify accuracy and completeness of medical information and associated documentation. 30%
• Interface with operational counterparts at Eisai affiliate and co-marketing partner locations, to assure the procedures and agreed implementation meet respective goals and regulatory responsibilities. 20%

Requirements

• Application of clinical medicine to patient care
• Medical terminology and standards of patient care
• Communications, medical writing skills
• Knowledge of International and US Regulations for reporting Adverse Events for Investigational and Marketed products.
• Minimum 5-7 years experience in an industry application of clinical medicine/pharmacy, including a minimum of 3 years experience in International Product Safety
• Knowledge of Clinical Development process in Pharmaceutical Industry
• Experience in verbally  interviewing and/or providing medical information to health care professionals.

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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