Clinical Safety Specialist

Há 3 dias


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.
Requirements
  • Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
  • Previous experience with general pharmacovigilance activities, including case processing and regulatory submissions.
  • Fluent English and intermediate Spanish.
  • General MS Office knowledge and Good Clinical Practice (GCP) related to clinical safety documentation.
  • Knowledge of ICH Guidelines and Medical Device reporting desirable.
  • Excellent verbal and written communication skills, with the ability to interact and influence with line and middle management, staff, and external contacts.
  • High degree of accuracy and attention to detail, with the ability to work as a team player.
About SAO Fortrea Brazil Limitada

We are a leading global contract research organization 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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