Clinical Safety Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro
Job Title: Clinical Safety Specialist

SAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions.

Key Responsibilities:
  • Assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process.
  • Manage and process expendable adverse events to the required standard and submit them to the client 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, COSHH regulations 1989, and EC 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, regulatory submissions, and quality control.
  • 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.

At SAO Fortrea Brazil Limitada, we are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. If you are a motivated problem-solver and creative thinker, we encourage you to apply for this exciting opportunity.


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