Product Safety Specialist

Product Safety Specialist (Remote) needed for a contract opportunity with Yoh Scientific's client located in Nutley, NJ.   Schedule: The ideal typical work hours will be from 7 am – 4 pm.   This position is for a major pharmaceutical company , and they are looking for someone who is a healthcare professional with at least 2-4 years of in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety.   Responsibilities

• Accurate and timely data entry of both domestic and foreign 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. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. 65%
• Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for reporting and confirmation of successful distribution and acknowledgement. 15%
• Maintain sufficient knowledge of all Eisai products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. 10%
• Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP's, SWP's and WID's. 10%
• Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer.