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Associate Ii Patient Safety Solutions

2-4 years
Not Disclosed
10 July 25, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Fortrea: Leading the Future of Clinical Development

Fortrea, a global contract research organization (CRO), is renowned for its scientific rigor and extensive clinical development experience. We offer a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for our partners and patients worldwide.

Primary Responsibilities

  • Post Approval Case Follow-Up: Conduct telephonic outreach to healthcare providers and consumers to collect safety data.
  • Adverse Drug Reaction Reporting: Record and report adverse drug reactions received through various communication channels, ensuring compliance with regulations and internal SOPs.
  • Safety Data Queries: Assist in generating queries of safety data for clients as needed.
  • Quality Assurance: Support activities such as tracking information and metrics, ongoing quality control of process steps, training, and data reconciliation from multiple sources.
  • Training: Create and update training materials based on procedural, system, and regulatory updates, and conduct training sessions to ensure effective learning.
  • Metrics Maintenance: Contribute to the generation and maintenance of Patient Safety Surveillance (PSS) metrics.
  • SOP and WI Adherence: Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), and other relevant documents related to safety management and pharmacovigilance.
  • Client Interaction: Assist in preparing for client meetings and liaise with clients as appropriate.
  • Core Competencies: Demonstrate role-specific core competencies consistently.
  • PSS Relationships: Build and maintain strong relationships across functional units within PSS.

Qualifications and Experience

  • Education:

    • Degree in Biological Sciences, Pharmacy, Nursing, or Life Sciences.
    • Associate’s degree in Nursing (RN) with 4 years of safety experience.
    • Bachelor’s degree (BS/BA) with 3 years of safety experience.
    • Master’s degree (MS/MA) with 2 years of safety experience.
    • Doctor of Pharmacy (PharmD) with 3 years of safety experience.
  • Skills:

    • Communication: Excellent verbal and written communication skills, with experience interacting with healthcare professionals and consumers.
    • Case Management: Experience in the book-in and triage of global complex cases.
    • Safety Submissions: Experience in safety submission is preferred.

About Fortrea

At Fortrea, we seek motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our mission is to revolutionize the development process, delivering life-changing therapies to patients swiftly. Join our exceptional team and thrive in a collaborative workspace that fosters personal growth, allowing you to make a significant global impact. For more information, visit www.fortrea.com.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on the needs of our business and the qualifications of the individual. We encourage applications from all qualified candidates, regardless of race, religion, color, national origin, gender, family or parental status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic.

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