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Pharmacovigilance Specialist - United States  

Company managed [?] Still accepting applications

Posted on : 13 June 2017

Project Description

Job Description 
  • Our company is  a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products. 
  • Founded in 1887 as a packager of home remedies, our company  has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. 
  • Our company  is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. 
  • The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs. Our company sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China.   
  • The Pharmacovigilance Specialist will receive, investigate and respond to adverse event/adverse experience reports, ensuring compliance with the Company’s investigation, documentation, and regulatory reporting, procedures. 



Required Experience            
  • Excellent communication skills, including strong verbal and interpersonal skills and good writing skills. 
  • Computer literacy, including Microsoft Office and computer applications used for collecting and processing adverse events and product complaints. 
  • Proven ability to read, understand, and apply U.S. and international law and regulatory guidance documents to job function. 
  • Previous experience interacting with the public and the ability to handle sensitive and stressful situations appropriately. 
  • Demonstrated knowledge of regulatory safety databases (ARGUS or equivalent). 
  • Ability to manage external US site case processing for submission to the appropriate regulatory authority. 
  • Ability to work under pressure with minimal supervision and deal effectively with confidential information. 
  • Extensive knowledge of company  products and their therapeutic uses, experience with medical coding or adverse event reporting, and working knowledge of FDA/EU/International regulations governing Adverse Event collection and reporting preferred. 
  • Bachelor’s Degree in the medical field or life sciences, with Nursing or Pharmacy degree preferred. 
  • Two to four years of experience in clinical practice and/or the pharmaceutical industry.