Senior Medical Reviewer Drug Safety Posted October 1, 2008 8 Years of Relevant Experience Summit, NJ

JOB DESCRIPTION: Responsible for: Ensuring medical accuracy of all aspects of the Case Management group's output Developing procedures in support of the Global Safety department having a significant medical context Ensuring internal escalation of cases as appropriate Contributing to the medical management of AE reports AE Case Management Manage & perform Medical Review: Execute the medical review of AE reports (narrative, coding, labeling, causality, company comment) Execute corrections and make updates in ARISg for minor modifications Execute corrections and return case to Assessment for major modifications Review and update generated follow-up letters as appropriate Sign off serious cases and cases of special interest Create and review weekly line listing of non-serious cases Manage any changes needed based on weekly line listing review of non-serious cases Distribute and discuss cases with other company MDs as needed Workflow Mgmt Contribute to the resolution of issues of case complexity Internal Coding Review and sign off synonym lists as required Conventions Maintenance Contribute to the creation & updating of conventions/templates Quality Assurance Contribute to the communication of quality performance findings Pharmacovigilance (approved products) PSURs Provide input to PSURs as required Events of Interest management Develop definitions of case follow up needs Product Launch Plan Contribute to product launch plan development & implementation Compliance, Standards, Training & Project Management  Preparation for Regulatory Inspection Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates Internal Global Safety Department Development Create Policies, guidelines, SOPs Participate in product meetings JOB REQUIREMENTS:  The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent. Qualifications MD or international equivalent Specialist accreditation preferred Experience Eight (5) years relevant experience, including training Four (4) years drug safety experience Process and systems management experience preferred Clinical experience preferred International co-operation Knowledge Medical aspects of drug safety Pre- and post-marketing safety practice Regulatory requirements across drug safety Clinical development process and operations