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Medical Director, Global Drug Safety Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2334138 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/2/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
0700467 Global Drug safety mission is to establish and maintain a system, organization and activities aimed at detection, assessment, understanding and prevention/minimization of adverse effects or any other drug-related problem, in the global frame of a Safety Risk Management process. Purpose of the Role As a member of the GDS, this position fully contributes to the ongoing and proactive monitoring of EMD Serono products both in drug development and post-marketing phase in Neurology. The primary role of the Drug Safety Physician is to identify and evaluate risk associated with a Merck Serono product, and accordingly make recommendations for the management and communication of the identified risk. Main Task and responsibilities Medically reviewing adverse event reports both for investigational and marketed products received from various sources, other relevant safety information emerging from the literature and experience with similar products Representing GDS in Clinical Teams for assigned products and contributing strategic input to safety-related activities pertaining to clinical trials e.g. devising the safety section of the protocol, defining safety biomarkers to be monitored Providing critical review of product-related documents (e.g. investigator brochures, protocols, study reports, informed consent form.) For marketed EMD Serono products, monitoring the safety of assigned products on an ongoing basis in order to identify and evaluate specific clinical/scientific safety issues; performing ongoing review of relevant literature pertaining to assigned investigational products Prepare the reviews and analyses of safety sections for worldwide regulatory authorities submission The approach is proactive and can lead to proposals or recommendations for changes in the Core Safety Information of EMD erono Marketed Products, recommendations for local labeling, proposals for specific retrospective or prospective safety studies, recommendations for the best approach to maintain Marketing Authorization approval in keeping with the most conservative means of ensuring patients' safety. Education & Languages MD degree is a pre-requisite Fluent English written and spoken French and other major European languages an asset Professional Skills & Experience Experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Clinical Safety) is desirable Basic knowledge of Epidemiology principles is desirable Experience working in a cross-functional matrix team environment is an asset Personal Skills & Competencies: Rigorous and well organized Good communication skills (both written and oral) Computer operation skills (i.e., word processing, generating reports from database software) Proficiency in prioritizing assignments and ability to adapt to rapidly changing priorities Analytical skills Please apply online at www.emdserono.com/career « Back to list
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.pharmaceuticalcrossing.com
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