Clinical Safety Specialist

hace 4 semanas


Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

About this role

Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

Our expertise

We offer full service-capabilities, resourcing and functional service (FSP) solutions.

As part of our team

You will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.

Key Responsibilities

  • Handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the Tfs/clients' SOPs and existing demands of the authorities.
  • Review and approval of 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.
  • Literature search.
  • 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.
  • May act as a Project Lead for Safety-only projects.
  • Participate in relevant meetings.
  • Forward information to relevant members of the department or study team members.
  • Provide internal support to other relevant departments.
  • Involved in improvement projects with other relevant departments.

About us

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

Our journey

We began over 27 years ago in Sweden, in the city of Lund.



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