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Safety Science Coordinator I

5+ years
Not Disclosed
10 July 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, 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

About Fortrea

As a leading global Contract Research Organization (CRO), Fortrea combines scientific expertise with decades of clinical development experience to offer comprehensive solutions in clinical development, patient access, and technology. Serving the pharmaceutical, biotechnology, and medical device industries, we operate across more than 20 therapeutic areas and have a workforce of over 19,000 professionals in more than 90 countries. Our mission is to transform drug and device development, enhancing outcomes for our partners and patients worldwide.

Role Overview

We are seeking dedicated and innovative professionals to join our team. In this role, you will support Clinical Safety and/or Pharmacovigilance operations for products, managing the entire adverse events process from clinical trials and post-marketing settings. Your responsibilities will include handling and processing expeditable adverse events, ensuring they meet required standards and are submitted to clients and regulatory agencies within agreed timelines. You will provide high-quality service in a safe and cost-effective manner, complying with the Health & Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in our Health & Safety Manual.

Key Responsibilities

  • Clinical Safety Management: Assist with Clinical Safety and/or Pharmacovigilance operations related to adverse events, including those from clinical trials and post-marketing settings.
  • Adverse Event Processing: Manage and process expeditable adverse events, ensuring timely submission to clients and regulatory agencies as required.
  • Quality Service Delivery: Provide exceptional service to both internal and external clients, maintaining safety and cost-effectiveness.
  • Compliance: Adhere to legal requirements and company safety standards, including Health & Safety regulations and European Commission directives.

Join Us

At Fortrea, we are committed to overcoming barriers in clinical trials and revolutionizing the development process. We offer a collaborative work environment where your personal growth is encouraged, and your contributions can make a global impact.

Fortrea is an Equal Opportunity Employer (EOE/AA):

We are dedicated to fostering diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender, family or parental status, marital status, sexual orientation, gender identity or expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For more information about Fortrea and how we handle your personal data, please visit www.fortrea.com and review our Privacy Statement.