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

The Drug Safety, Pharmacovigilance Specialist is responsible for receipt and documentation of safety information for Marketed and Investigational Products. They interact with health professionals and consumers to obtain and follow-up on reports of possible adverse events with Eisai products. The Specialist will provide product information to health care professionals, consumers, and sales representatives and code and enter information into the global safety database. He/she will verify the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Moreover, they will assure consistency of case records and documentation and create and ensure distribution of regulatory reports for FDA and other regulatory health authorities.

Essential Functions

• Accurate and timely data entry of domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ Company Core Data sheet, PI, and/or IB for accurate labeling and listedness.  Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. 70%
• Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes.  Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. 10%
• Perform appropriate and timely follow-up/querying according to department guidelines and professional judgment, including accurate and thorough documentation within the case. 10%
• Maintain sufficient knowledge of all Eisai products and therapeutic areas to ensure professional and knowledgeable discussions with consumers and healthcare providers, as well as dissemination of accurate product information in response to queries.  Provide high level customer service to consumers, health care professionals and internal customers. 10%