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Specialist Training - Patient Safety Solutions

3+ years
Preferred by Comapny
12 Nov. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Job Title: Training Specialist, Patient Safety
Location: São Paulo, Brazil
Time Type: Full-Time
 

About Fortrea

Fortrea is a global leader in contract research organizations (CRO), providing pharmaceutical, biotechnology, and medical device clients with clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is at the forefront of transforming drug and device development to meet the needs of patients worldwide.

Position Overview

We are looking for a Training Specialist to develop and deliver high-quality training programs for our Patient Safety (PSS) team. This role will focus on creating and executing role-specific training, managing external vendors, and ensuring the certification of Drug Device safety professionals. You will also collaborate with various teams to enhance departmental compliance and contribute to the development of safety systems and processes.

Main Responsibilities

  • Develop and deliver PSS curriculums in collaboration with technical training teams.
  • Manage external training vendors to create training content for system-related topics.
  • Design and implement role-specific training programs.
  • Evaluate and approve Safety Database (SDB) training, including test cases and user access for production.
  • Coordinate with SDB trainers to ensure test cases are reviewed.
  • Develop and manage role-specific certification programs (e.g., certified case processor, certified QCer) for Drug Device safety professionals.
  • Conduct periodic re-training and address training needs as required.
  • Support QA liaison in preparing for audits and inspections.
  • Collaborate with PSS physicians to deliver training on medical terminology and therapeutic area-specific content.
  • Partner with Project Managers to develop and deliver project-specific training.
  • Review departmental compliance and contribute to achieving departmental objectives.
  • Assist in the development and execution of Corrective and Preventative Actions (CAPAs) related to training.
  • Develop and deploy job aids and reference guides, and contribute to the periodic review and update of Standard Operating Procedures (SOPs).

Main Requirements

  • Education: Bachelor's degree in healthcare or a related field.
  • Experience:
    • Strong experience in pharmacovigilance and PV reporting.
    • Experience with Argus Safety software.
    • Experience in Quality Control (QC) is a plus.
  • Skills:
    • Fluent in English (written and verbal).
    • Strong communication and organizational skills.
    • Ability to collaborate with cross-functional teams and manage training projects.

Why Fortrea?

At Fortrea, we believe in the power of collaboration, creativity, and passion. We are committed to revolutionizing clinical trials to ensure the swift delivery of life-changing therapies to patients in need. Joining our team means embracing personal and professional growth while making a meaningful impact on a global scale.


Fortrea is an Equal Opportunity Employer
Fortrea is dedicated to fostering diversity and inclusion and does not tolerate harassment or discrimination of any kind. We encourage all qualified individuals to apply.

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