US Patient Safety Specialist

Wilmington, DE 19850

Posted: 04/22/2019 Industry: Other Area(s) Job Number: 34913

US Patient Safety Specialist

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  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 and support to the product teams. The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams  to provide case handling and safety support to licensing agreements, clinical study agreements and special projects.

• Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 2 years of Patient Safety experience

• 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 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 (Jasper)

• Have a broad understanding of Support & Surveillance activities and the impact on individual case or group of cases can have on product labelling

• Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports

• Represents US Patient Safety in Licensing Agreement review and process teams

• Represents US Patient Safety for Clinical Trial protocol and safety handling plan review and process teams

• Assumes responsibility for completing special projects (i.e. CIPs, representation on cross functional teams)

• Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and US Medical Affairs 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, collection of safety data and FDA processes and regulations

• 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

 

Required:

• Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 3 years of Patient Safety experience

• 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 

• Demonstrates leadership capabilities at target level or above

• Ability to travel domestically for yearly business meeting The Senior Specialist must, in addition, meet the following requirements:

• Works as a team player and supports the development of other team members

• Excellent knowledge of FDA regulations and ICH guidelines

• Provides training and mentoring of Patient Safety staff on local and global adverse event reporting, project work and with respect to career development

• Demonstrates leadership ability by conducting team meetings independently and managing special projects

 
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