Wilmington, DE - Safety Specialist

JOB DESCRIPTION:

• The US Patient Safety Specialist serves as a Medical and Safety resource for synthesis, analysis, evaluation, and reporting of adverse event information in order to maintain an accurate safety products
• The US Patient Safety Specialist serves as vital link in the timely classification, analysis and summarization of both investigational and post-marketed adverse event information
• The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams within the company

ACCOUNTABILITIES / RESPONSIBILITIES:

• Participates in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information
• Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
• Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
• Enter and maintain accurate tracking system for all AE reports (CRIMSON)
• Have a broad understanding of Surveillance activities and the impact on individual case or group of cases can have on product labeling
• Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports
• Assumes responsibility for completing special projects (i.e. IND Annual Reports, PSUR table preparation)
• Supports Safety Surveillance, Safety Support  - Compliance and Marketing Company and the US Clinical Teams
• Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues

REQUIREMENTS:

• Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
• Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
• Working knowledge of technology required for Patient Safety
• Excellent knowledge of FDA and ICH guidelines and reporting requirements
• Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least two years of experience in Patient Safety
• Bachelor s degree in science / healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background.  Advanced degree is preferred
• Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
• Broad competence with medical, therapeutic and technical terminology
• Able to work effectively as part of a cross functional team
• Excellent verbal and written communication skills
• Demonstrated capabilities in Project management, Time management, Presentation skills
• Strong attention to detail and organization
• Demonstrated ability to perform with minimal supervision
• Works as a team player

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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