Job Description
KV Pharmaceutical seeks a pharmacoviligance associate. The successful candidate will provide global drug safety and pharmacovigilance surveillance for marketed and investigational products, including the drug safety call center operation, data/case management and associated functions, medical review, analysis of data, regulatory reporting and associated aspects of drug safety surveillance. This position requires substantial knowledge of GCPs, US, ex-US and ICH regulatory requirements for pharmacovigilance of marketed drug products and drug safety of investigational clinical trials. You will provide case management and maintain pharmacovigilance and drug safety operations as well as conduct medical assessment, determine additional information needed and independently generate drug safety. Other responsibilities include adherence to adverse event coding conventions and assure use of appropriate software and dictionaries (e.g., MedDRA, COSTART), preparation of individual (e.g., 7-day, 15-day) and periodic reports and development and implementation of US and ex-US risk assessment/management strategies. You will perform periodic medical literature search and review, trend analysis and signal generation and establish and maintain a network with all licensing and business partners for coordinated reporting.
Medical training and education (RN, NP, PA, RPh, PharmD) plus a minimum of three years experience in a medical or pharmaceutical safety reporting required. The successful candidate must have strong knowledge of worldwide safety regulations for marketed and investigational products. You must understand and have industry experience in drug safety and pharmacovigilance and FDA and global regulations related to drug safety reporting, ICH guidelines, and GCP and the processes required to comply. We are seeking detail-oriented individuals who possess excellent verbal and written communication skills, math skills, offer an organized approach to providing timely accurate reports, can multi-task, prioritize, and are proficient in Microsoft Office.
With 13 consecutive years of record revenues, KV Pharmaceutical Company (www.kvph.com), a high-growth organization, has reported a year-over-year net revenue increase of 35.7% to over $600 million for Fiscal 2008.
KV Pharmaceutical (NYSE: KVa/KVb), is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. With more than 65 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded products.
KV is based in St. Louis, Missouri, which was recently named as a 2008 All-America City by the American City Business Journals, one of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005. St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities.
KV Pharmaceutical provides a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental. We offer competitive salaries and stock options for many positions which have proven to be lucrative to many long-term KV employees.
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