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The Cyber-Spy.Com Usenet Archive Feeds Directly From The Open And Publicly Available Newsgroups These Group And Thousands Of Others Are Available On Most IS NNTP News Servers On Port 119. Cyber-Spy.Com Is NOT Responsible For Any Topic, Opinions Or Content Posted To These Or Any Other Newsgroups. This Web Archive Of The Newsgroups And Posts Are For Informational Purposes Only. Message-ID: <031013120047139.NP32138@jobcircle.com> Newsgroups: us.jobs.offered,alt.bestjobsusa.computer,alt.bestjobsusa.computer.jobs,alt.bestjobsusa.jobs.offered From: versatechxx99@jobfrenzy.com (JobCircle.Com) Reply-To: versatechxx99@jobfrenzy.com Subject: US-NJ: Pennington-Associate Director - Safety Scientist Date: Mon, 13 Oct 2003 12:00:48 GMT NNTP-Posting-Host: 207.106.112.162 NNTP-Posting-Date: Mon, 13 Oct 2003 08:00:48 EDT Organization: JobCircle.com (jobcircle.com) ************************************************************** JobCircle.com - Careers, Content and Community for Technology professionals in the Northeastern United States! Jobcircle.com provides resume submission, classified searches, eLearning, hundreds of career development articles, tech news, and more to tens of thousands of Technology professionals in your area - visit us today at http://www.jobcircle.com! !!! Voted a TOP 50 Career Web Site in 2002 by CareerXRoads !!! ************************************************************** Please reply to versatechxx99@jobfrenzy.com with your resume! Job Title: Associate Director - Safety Scientist Job Location: NJ: Pennington Pay Rate: Open Job Length: full time Start Date: 2003-10-13 Company Name: VersaTech Consulting Contact: Recruiting Department Phone: 732-726-4200 Fax: 732-326-0160 Description: Description: Supervise a team of Senior Safety Scientists to provide clinical, technical, analytical, and writing support to GPL Medical Directors for all aspects of safety data analysis, evaluation, and reporting. Prioritize team activities to support Medical Directors' data analysis and reporting needs, in consultation with GPL Executive Director, when appropriate. Participate with GPL Medical Directors in ongoing safety monitoring of assigned investigational and marketed products. Oversee, prioritize, and coordinate team activities for all aggregate reporting, including IND Expedited Reports, IB updates, PSURs, US PRs, expert reports, responses to ad hoc queries, label updates, etc., in consultation with GPL Medical Directors. Supervise and, in consultation with Medical Directors, advise safety scientists concerning analysis of safety issues arising from clinical trials or post-marketing surveillance. Develop uniform approaches and standards for safety data analysis and aggregate reporting, in conjunction with GPL professional and senior staff. Ensure adherence to data analysis and reporting standards across all therapeutic areas and products. Work closely with Data Entry Managers and Medical Directors to develop and maintain data entry standards that optimize the utility of CARES data for pharmacovigilance. Supervise Safety Scientist liaison with personnel in clinical research, other departments inside and outside PRI, CROs, and other companies. Represent GPL at CWG and PWG FDT meetings, NDA MAA taskforces, and other internal or external meetings. Take a proactive role in GPL Standard Operating Procedure policies and Work Practices through periodic review and or by proposing solutions to identified areas for improvement. Assesses developing safety information, anticipates potential impact, communicates implications and develops strategies for clinical and regulatory issues. Deals with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Identifies new and more efficient processes for safety assessment, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment. Thinks clearly and decisively and presents independent, reasoned solutions to identified safety issues. Is an active, high-energy proponent of the company's commitment to the public health. Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Represents GPL within areas of responsibility and competence experience. Provides leadership and contributes to or coordinates activities of core marketed product teams. Builds and manages interrelationships by motivating and inspiring people by example. Familiarity with regulatory guidelines and references. Bachelor's degree required, Nursing, PharmD Master's preferred with a minimum of 2-4 years in pharmaceutical experience. Experience in post marketing pharmacovigilance required. Maintain an extensive, detailed knowledge of worldwide regulations, policies and procedures relating to drug safety and communicate them to direct reports. Maintain close professional contact with the medical and scientific community through active participation in and presentations to professional organizations, symposia, and continuing education programs. Develop these skills in direct reports through supervision, mentoring, and other appropriate methods of on the job training. These duties and responsibilities help protect patients and consumers, directly and indirectly meet worldwide regulatory obligations pertaining to drug safety analysis and reporting, help achieve company cost effectiveness goals, and strengthen people skills and reputation as employer of choice in the pharmaceutical industry. Experience: Desired skills: . FOR IMMEDIATE CONSIDERATION PLEASE FORWARD YOUR RESUME TO: 1108786.99@JobFrenzy.com Please send to attention of Dan Charlebois. Required Skills: Associate Director - Safety Scientist This is a Full Time Position. Please refer to Job code 111297 when responding to this ad. For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/372257.html to apply online. ************************************************************** For fastest processing of your resume, this employer asks that you apply to this job using the URL above. ************************************************************** Go Back To The Cyber-Spy.Com Usenet Web Archive Index Of The alt.bestjobsusa.jobs.offered Newsgroup |
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