Clinical Safety Specialist

2 semanas atrás

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

As a leading global contract research organization (CRO), SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Key Responsibilities:

Assist with the overall Clinical Safety and/or Patient Safety Solutions operations associated with products, including the entire adverse events process, which may include safety data collected from clinical trials and/or post-marketing settings.

Manage and process expendable adverse events to the required standard and submit them to the client and regulatory agencies (if required) within the agreed timelines.

Provide high-quality service to clients, both internal and external, in a safe and cost-effective manner.

Main Requirements:

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

SAO Fortrea Brazil Limitada is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

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