US-MA: Boston-Pharmacovigilance Physician

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Job Title: Pharmacovigilance Physician
Job Location: MA: Boston
Pay Rate: Open
Job Length: full time
Start Date: 2008-01-04

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Pharmacovigilance Physician

The Pharmacovigilance Physician will handle medical review and analysis of serious adverse event reports. You will act as responsible PV physician for designated development products for clinical trials and programs and participate in analysis and preparation of safety data for internal and external use. The Pharmacovigilance Physician will also interface with other functional areas on safety matters. Responsiblities include: review medical content, coding, expectedness, company seriousness and causality and to provide final follow-up requirements for serious adverse event case reports; review of case narratives for submission documents; in collaboration with Data Management, review and sign off of coding from clinical trials; facilitate and execute reconciliation of clinical and safety databases; perform activities required to serve as PV physician; represent Department on Study Teams (working groups, sub-teams) for assigned products; provide content and review study related documents including: protocols, IBs, ICFs, CRFs, SAPs, CSRs; develop and implement safety process plans for regulatory reporting and safety letter reporting for clinical trials; contribute to preparation and review of periodic reports (IND/Annual Safety); participate in the analysis of safety data from on-going and completed clinical trials; review of product complaints for adverse events; and participate in departmental development activities including SOP and Work Instructions initiation and development. Qualifications include: an M.D. degree; 1-2 years clinical experience following post-graduate training with significant knowledge of general medicine; strong leadership skills; the ability to collaborate with several cross-functional teams; good level of computer literacy with Microsoft applications; excellent analytical and problem solving skills; excellent oral and written communication skills; clinical research and/or industry experience in Safety or in Clinical Development; and knowledge of principles of epidemiology and statistics is desired.

Please refer to Job code BG4826 when responding to this ad.


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