Clinical Safety Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro
Job Summary

SAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist to join our team. As a key member of our Clinical Safety and Patient Safety Solutions operations, you will play a critical role in ensuring the safety and efficacy of our products.

Key Responsibilities
  • Manage and process adverse events to the required standard and submit them to clients and regulatory agencies within agreed timelines.
  • Provide high-quality service to clients, both internal and external, in a safe and cost-effective manner.
  • Comply with legal requirements, including the Health & Safety at Work Act 1974 and the EC (European Commission) Directives 1992/3.
  • Collaborate with cross-functional teams to ensure seamless operations and achieve business objectives.
  • Develop and maintain knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
Requirements
  • Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
  • Previous experience in pharmacovigilance activities, including case processing and regulatory submissions.
  • Fluent English and intermediate Spanish.
  • General MS Office knowledge and proficiency in Good Clinical Practice (GCP) related to clinical safety documentation.
  • Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
About SAO Fortrea Brazil Limitada

We are a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.


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