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Regulatory Affairs Expert

hace 3 semanas


Torre Pacheco Campo de Cartagena y Mar Menor Spain Exeltis A tiempo completo
About Us

Exeltis is a leading organization committed to innovation, excellence, and healthcare. Our aim is to become a point of reference in the pharmaceutical sector.

Job Description

We are seeking a highly skilled Regulatory Affairs Expert to join our team at Exeltis. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety and well-being of clinical trial participants.

  • Conduct safety monitoring of interventional phase I, II, III clinical trial activities.
  • Provide recommendations and guidance to study clinical operation teams and Contract Research Organizations (CRO) personnel.
Responsibilities

The successful candidate will have the following responsibilities:

  • Safety reporting of SAEs / SUSARs to health authorities, ethics committees, and clinical trial investigators.
  • Develop safety protocols and procedures for clinical research studies.
  • Monitor the safety of clinical trial participants and ensure compliance with safety guidelines.
Requirements

To be considered for this role, you will need:

  • A degree in Science (e.g. Pharmacy, Biochemistry, Biology) or medical degree.
  • Fluent English language skills (verbal and written).
  • +3-5 years' experience with clinical trial operations and safety reporting in a pre and post marketing setting.