Manager - Pharmacovilgilance
Location: South Waltham Massachusetts
Description: Commonwealth Sciences, Incorporated is in need of Manager - Pharmacovilgilance right now, this vacancy will be placed in Massachusetts. For complete informations about this vacancy opportunity please read the description below. Responsibilities:
Provide oversight and coordination of the adverse event reporting process, including tracking of AE reports, triage, data ent! ry, 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
Experie! nce with regulatory audits
Candidates must live local! and be a US Citizen or Green Card Holder
Email resume to:
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.
www.cwsciences.com
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Commonwealth Sciences, Incorporated.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Mon, 19 Aug 2013 14:01:16 GMT