Clinical Safety Specialist

hace 2 días

Barcelona, Barcelona, España Tfs Healthscience A tiempo completo
Job Title: Clinical Safety Specialist

At Tfs Healthscience, we are seeking a highly skilled Clinical Safety Specialist to join our team. As a key member of our Safety and Regulatory Services (SRS) team, you will be responsible for ensuring the safe and effective handling of clinical trials and post-marketing surveillance.

Key Responsibilities:
  • Review and approve processed cases and AE/SAE reconciliation
  • Coding of adverse event, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary
  • QC and approval of coding of adverse event, medical history, and concomitant medication
  • Review and write the safety section in clinical study protocols
  • Review of clinical trial reports/IBs from a safety perspective
  • Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA, and other safety documents
  • Electronic reporting to EudraVigilance
  • Contribute to plans/instructions and SOPs for post-approval surveillance
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs
Requirements:
  • Bachelor's Degree, preferably in life science or nursing; or equivalent
  • 3 years of experience in the position
  • Able to work in a fast-paced environment with changing priorities
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
What We Offer:

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.

You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

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