Manager - Pharmacovilgilance
Location: Waltham Massachusetts
Description: Commonwealth Sciences is at the momment seeking for Manager - Pharmacovilgilance right now, this occupation will be placed in Massachusetts. More complete informations about this occupation opportunity please give attention to these descriptions. Responsibilities:
Provide oversight and coordination of the adverse event reporting process, including tracking of AE reports, tri! age, data entry, case processing, distribution to stakeholders and submission of applicable AE reports to the health authority
Responsible for optimizing the use of the validated safety database to achieve consistency in data and reporting output
Developing and managing safety exchange agreements and other PV contracts
Coordinating and managing the compilation of aggregate safety reports (e.g., PSURs, ASRs)
Coordinating the compiling aggregate safety data for internal review
Providing safety-related expertise on cross-functional project teams.
Requirements:
BS/MS in Nursing, Pharmacy or related field with 5+ years experience
Must have experience in all aspects of global safety reporting for clinical studies and marketed products, including MedDRA and WHODD coding with a thorough understanding of the global PV regulatory environment with working knowledge of FDA regulations, ICH guidelines, and GCP
Experience with regulatory audits
Candidates mu! st live local and be a US Citizen or Green Card Holder
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.
To apply for this job, send your resume to jobs@cwsciences.com
- .
If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Commonwealth Sciences.
If you interested on this occupation just click on the Apply button, you will be redirected to the official website
This occupation starts available on: Tue, 10 Sep 2013 14:31:39 GMT