Clinical Safety Associate

2 semanas atrás


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

Job Overview:

As a Clinical Safety Associate at SAO Fortrea Brazil Limitada, you will play a crucial role in ensuring the safety and efficacy of our clients' products. Your primary responsibility will be to assist with the overall Clinical Safety and/or Pharmacovigilance operations associated with products, including the entire adverse events process.

Key Responsibilities:

  • Perform case intake and triage of incoming safety information or reports from various sources.
  • Assist with processing of adverse events, including data entry, writing patient narratives, and coding adverse events accurately using MedDRA.
  • Assist in the listedness assessment against appropriate labels and generation of queries and collection of missing or discrepant information.
  • Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other recipients within agreed timelines.
  • Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients.
  • Reconcile databases and maintain supporting files/documentation regarding adverse event reporting requirements.
  • Support upload/archival of case/study/project documentation and build and maintain good PSS relationships across functional units.
  • Support compliance of operations with governing regulatory requirements.

Requirements:

  • BA/BS Degree in healthcare courses.
  • Both English and Spanish fluency.
  • Basic MS Office knowledge.

About SAO Fortrea Brazil Limitada:

SAO Fortrea Brazil Limitada is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.


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