Clinical Safety Specialist

4 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 Clinical Safety Specialist, you will play a critical role in ensuring the safety of our clients' products and patients.

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, COSHH regulations 1989, and EC Directives 1992/3, as documented in the Company's Health & Safety Manual.
Requirements:
  • Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
  • Previous experience in general pharmacovigilance activities, including case processing, regulatory submissions, and quality control.
  • Fluent English and intermediate Spanish.
  • General MS Office knowledge.
  • Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation and ICH Guidelines.
  • Knowledge of Medical Device reporting desirable.
  • Good verbal and written communication skills and good presentation skills.
  • Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
  • High degree of accuracy with attention to detail.
  • Functions as a team player.

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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