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Astellas is hiring Senior Medical Director

Astellas is hiring Senior Medical Director
Posted By: Jehan Bunch on April 03, 2009

Job Description:

Astellas is the bright spot in the pharmaceutical industry – not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us! Astellas is announcing a Medical Director, Pharmacovigilance opportunity in our Deerfield, IL location. This position is responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations. Additionally responsible for strategies in monitoring and analysis of cumulative safety information on Astellas products. Responsible for drug safety crisis management Specific responsibilities include: 1. Guides regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and Periodic Safety Update Reports (PSURs) 2. Guides adverse event coding, retrieval and analysis activities in drug safety and clinical trials 3. Guides reviews of safety sections of NDA submissions 4.



Plans cumulative safety information analysis such as signal detection from company or public databases with data mining 5. Guides safety updates of company core data sheet and local product labels 6. Guides pharmacoepidemiology projects 7. Guides crisis management on drug safety 8. Guides Risk Management Plans for specific products 9. Guides and coordinates preparation of ad-hoc benefit-risk assessment documents 10. Guides regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees. 11. Interfaces with Medical Sciences, Clinical Studies, Product Safety Management, Drug Development and Project Management, Pharmacoepidemiology, Global Pharmacovigilance departments, Toxicologist, Biopharmaceutical sciences, Research Data Sciences, Legal Position

Requirements:

MD degree, Pharmaceutical Industry experience in Pharmacovigilance and drug safety for at least five years, Team working, analytical skills, and flexibility are essential for this position.

This position is currently accepting applications. © The RightThing, Inc 2008 (If you encounter technical problems or difficulties, email tech1support@rightthinginc.com or call 1-888-772-9773, M-F 8-5 EST.) (If you have process questions, email processsupport@rightthinginc.com ) ABOUT SSL CERTIFICATES

https://www.appone.com/MainInfoReq.asp?R_I...
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