Mgr. Safety Quality Assurance, Global Drug Safety Posted November 21, 2008 5-10 Years Experience Summit New Jersey

JOB DESCRIPTION: Responsible for: •          QA validation of key department outputs •          Continuous improvement initiatives •          Process enhancement initiatives Purpose •          To assure quality of key outputs of the Global drug safety department including case management, trials support and pharmacovigilance. •          To act as the catalyst for continual improvement initiatives Outputs •          Quality assured reports and reviews •          Quality performance metrics •          Continuous improvement initiatives JOB REQUIREMENTS: Skills/Knowledge Required: •          Minimum of B.S. or the equivalent combination of relevant education or professional experience •          Advance degree preferred Experience       •          Five (5) years relevant experience, including training •          Three (3) years pharmaceutical/biotechnology industry experience •          Drug safety experience Knowledge •          Expert knowledge of the safety regulatory environment •          Proficiency in technical safety systems including ARISg and medical coding •          Computer and database skills Competencies •          Attention to detail •          Diplomacy •          Communication (written & oral) •          Organisation and planning