Patient Safety Associate/ Drug Safety

Job Title: Patient Safety Associate
Reports To: Director, US Patient Safety Operations
Job Location: Wilmington, DE 19850
Duration: 4 Months

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 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.

Typical Job Accountabilities/Responsibilities

  • Participates in the triage process and data entry 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
  • Subject Matter Expert in PV related activities - Case Handling, FDA regulations, ICH/GCP guidelines and EU regulations
  • Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
  • Demonstrates effective leadership, communication and project management skills including issue and risk management as well as the ability to collaborate and lead cross-functional PV related projects
  • Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA / AZ processes and regulations
  • Drives continuous process improvements within Patient Safety
  • 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
  • Demonstrates leadership capabilities at target level or above


Education, Qualifications, Skills and Experience
Essential

  • 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 2 years of Patient Safety experience
  • 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


Desirable

  • Professional qualification
  • Project Management experience


Note: This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, colour, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at NAhr@spectraforce.com if you require a reasonable accommodation.
For the full list of our open positions, please check www.spectraforce.com



Job Requirements:
  • Typical Job Accountabilities/Responsibilities
    • Participates in the triage process and data entry 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
    • Subject Matter Expert in PV related activities - Case Handling, FDA regulations, ICH/GCP guidelines and EU regulations
    • Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
    • Demonstrates effective leadership, communication and project management skills including issue and risk management as well as the ability to collaborate and lead cross-functional PV related projects
    • Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA / AZ processes and regulations
    • Drives continuous process improvements within Patient Safety
    • 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
    • Demonstrates leadership capabilities at target level or above
Posted
09/11/2021
Type
Full time
Location
Atlanta, GA 30383, US