Medical Reviewer/Safety Reviewer Job in Chicago, Illinois US
Medical Reviewer/Safety Reviewer
Drug Safety Specialist Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a 12 month contract opportunity for a Drug Safety Specialist in Abbott Park, IL . Job Summary Responsibilities include medical review, which involves in-house review of Case Report Forms CRFs including query resolution and addenda writing, QA of data listings. Job Responsibilities (other duties may be assigned): Adverse Event Reporting: The investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA. Medical Communication: Includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. (Off-label information would be disseminated at this level.) Responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies. Provide training internally and at investigator meetings on safety issues. ?? Education and experience required : Bachelors of Science in Nursing (BSN) or Registered Nurse (RN) 5 or more years of pharmaceutical experience For immediate consideration, click the Apply Now! button, or refer a friend by clicking the E-mail this job link provided. Kelly Scientific Resources has?grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.