US Patient Safety Specialist

Hiring By - Biostaffic

 BioPharma

Wilmington, Delaware - United States

Job Highlights

Not Disclosed

Entry level

Posted 4 months ago
Job details
Wilmington, DE
Contract Duration: 8-36 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities
  • Excellent employment opportunity for a US Patient Safety Specialist in the Wilmington, DE area. ONSITE
  • 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 Company 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 Company to provide case handling and safety support to licensing agreements, clinical study agreements and special projects.
  • 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
  • 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
  • Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
  • Initiates and volunteers for special projects
Experience
  • 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
  • Have a broad understanding of Support & Surveillance activities and the impact on individual case or group of cases can have on product labelling
  • Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA / Company processes and regulations
  • Working knowledge of technology required for Patient Safety
  • Excellent knowledge of FDA and ICH guidelines and reporting requirements
  • Demonstrated ability to perform with minimal supervision
  • Demonstrates leadership capabilities at target level or above
  • Ability to travel domestically for yearly business meeting

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Wilmington, Delaware - United States

Experience:

  • Entry level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
Fladger Associates
Fladger Associates

Current Openings: 0

Fladger Associates is a professional, national executive search and human capital solutions firm specializing in licensed, degreed, or certified professionals in: . Pharmaceutical Clinical Research, Information Technology, Engineering, and Medical Technology Our Passion - Building Long Term Client Partnerships that satisfy your requirements for the very best Human Resources while providing career development opportunities for our candidates. Fladger Associates excels at identifying highly qualified professionals to whom our clients might not otherwise have access. You will find that we operate differently than most firms in the industry, we care about matching the clients and candidates, to ensure that requirements and cultures match. How We Work We leverage a vast network of relationships, specialized industry knowledge, state of the art research, and proprietary management software to provide the comprehensive coast-to-coast coverage needed to find highly qualified topnotch candidates for client requirements.
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