Pharmacovigilance Scientist

Job description

Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies. Activities Include: *May Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and reporting; prioritize ICSR according to regulatory requirements *Confirmation of Safety Coordinator case registry data *Database searches as necessary *Completion of remaining case data entry, including narrative or auto-narrative *Completion of risk and quality (label, approval, manual coding and quality review steps). *Clarification of unclear or illegible information from the LSO or Call Centre *Discussion of source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician *Request deletions as necessary *Single case unblinding EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. *Registered Nurse OR *Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR *Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually exhibited by minimum 5 years experience in pharmaceutical safety-related role. Please Contact Me @ 732-429-1635 A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.