- 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%
- Bachelor's degree in medical field with RN or RPh licensure, or PharmD/MD degree required.
- Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety
- Experience in verbally interviewing and/or providing medical information to health care professionals and consumers.
- Application of clinical medicine to patient care
- Medical terminology and standards of patient care
- Computer proficiency
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Product Safety Specialist - Nutley, United States - Eisai
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.
Job Summary
Responsible for receipt and documentation of safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with Eisai products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities
Essential Functions
Requirements
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Eisai Salary Transparency Language:
The base salary range for the Product Safety Specialist is from :85,000-111,500 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
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.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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