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Pspm Support Associate

3+ years
Preferred by Comapny
11 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: Safety Support Specialist
Location: São Paulo, Brazil
Time Type: Full-Time
 

About Fortrea

Fortrea is a leading global contract research organization (CRO), providing clinical development, patient access, and technology solutions across over 20 therapeutic areas. With operations in more than 90 countries, we are committed to transforming drug and device development to improve the lives of patients worldwide.

Position Overview

We are looking for a Safety Support Specialist to join our team and support the set-up, maintenance, and close-out of global and regional clinical trials or post-marketing studies. This role involves supporting the Global Safety lead in various tasks, including the preparation of safety management plans, training materials, and safety-specific documentation, as well as assisting in the maintenance of safety databases and ensuring compliance with safety reporting regulations.

Main Responsibilities

  • Assist with the set-up, maintenance, and close-out of global or regional clinical trials and post-marketing studies.
  • Support the Global Safety lead in the preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-related documents.
  • Help in creating study-specific job aids, training materials, and templates.
  • Assist with systems set-up and ongoing maintenance during study start-up.
  • Provide support with functional management tasks, including access requests and training assignments.
  • Assist with the reconciliation of safety databases when required.
  • Draft, modify, and deliver safety presentations for both internal and external stakeholders.
  • Help generate monthly status reports and project-specific reports, ensuring the accuracy and quality of data.
  • Assist in Trial Master File (TMF) management activities as needed.
  • Support the preparation of safety documentation for internal, client, or regulatory audits.
  • Maintain a thorough understanding of Fortrea’s Standard Operating Procedures (SOPs) and other relevant documents.
  • Ensure compliant safety reporting according to US and international regulations, SOPs, and safety guidelines.
  • Demonstrate role-specific competencies and company values consistently.

Qualifications

  • Education: Bachelor's degree in a relevant field (e.g., life sciences, healthcare, etc.).
  • Experience:
    • Prior experience in safety support within clinical trials, pharmacovigilance, or a related field.
    • Familiarity with safety database management and clinical trial processes is a plus.
  • Skills:
    • Strong organizational skills and attention to detail.
    • Proficient in English (written and verbal).
    • Ability to collaborate with internal and external teams.
    • Knowledge of safety reporting regulations and guidelines.

Why Fortrea?

At Fortrea, we are committed to revolutionizing the development process of clinical trials and ensuring the swift delivery of life-changing therapies. We offer a collaborative work environment that nurtures personal and professional growth, allowing you to make a meaningful global impact.


Fortrea is an Equal Opportunity Employer
Fortrea is committed to diversity and inclusion and does not tolerate harassment or discrimination. Employment decisions are based on business needs and the qualifications of the individual. We encourage all qualified applicants to apply.

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