St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 11:43:45.764350USAPlymouthSenior Clinical Safety Specialist Job Requisition #: 12987 Date Posted: 04/20/2012 Category: Clinical Location: Plymouth - MN - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth. Job Overview The Senior Clinical Safety Specialist will work under the direction of the Senior Director, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects. Responsibilities: • Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting • Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings • Oversee weekly review of adverse events with applicable study teams • Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP) • Code adverse events where directed by the governing processes • Draft AE narratives, as required, for inclusion in all FDA report submissions • Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events • Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products • Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting • Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department • Assist in development of study specific case report forms • Assist in clinical study protocol development • Assist with BIMO audits, when directed • Collaborate on additional Clinical Research activities, as needed • Other duties as assigned Requirements: • Bachelor’s degree in an area of science or RN • Strong understanding of adverse events and risk assessment One of the following: • 2-5 years experience within pharmacovigilance or medical safety • 5+ years experience in medical device or Pharma in clinical research or risk assessment • Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards • Proficient in MS Office and database navigation skills • Strong interpersonal and communication skills • Excellent record keeping, organizational skills, and problem solving abilities • Highly motivated and capable of working independently and as a team member • Experience coordinating, prioritizing, and setting timelines for multiple tasks • Ability to multi-task and adapt to a rapid pace environment • Strong technical writing skills Preferred qualifications: • 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena • PharmD or PhD |E-mail this position Submit Resume or C.V.2012-04-20 18:09:08United StatesSt. Jude MedicalMinnesota12987MNPlymouth, MN28034690http://jobs.sjm.com/xml/28034690/job