Wilmington, DE - Safety Advisor

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 profile of the company's 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 insure 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 time frames
• 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
• 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
• Initiates and volunteers for special projects
• Demonstrates leadership capabilities at target level or above

REQUIREMENTS:

• 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)
• 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
• 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

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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