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Patient Safety Operations Specialist - A

TechData Service Company LLC Wilmington, DE
  • Posted: 26 days ago
  • Contractor
  • Benefits: Medical, Dental

Company: Large Pharmaceutical Company

Contract Position: 1 year with potential contract extension

Title: Patient Safety Operations Specialist

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 CLIENT 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 within CLIENT to provide case handling and safety support to licensing agreements, clinical study agreements and special projects.

Responsibilities:

  • 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 / CLIENT 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

· Initiates and volunteers for special projects

· Demonstrated ability to perform with minimal supervision

TechData Service Company LLC

Address

1800 Concord Pike
Wilmington, DE
USA

Website

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