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Clinical Safety Specialist
2 meses atrás
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.
- 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 others.
- 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 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.
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.
