This job is currently Archived,
Pharmacovigilance Specialist - United States
Posted on : 13 June 2017
- 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.
- 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.