Clinical Safety Specialist

hace 3 días

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

Key responsibilities
  • Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with Tfs Healthscience and clients' SOPs and existing regulatory demands.
  • Review and approval of processed cases and AE/SAE reconciliation.
  • Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
  • Quality control and approval of coding of adverse events, medical history, and concomitant medication.
  • Review and writing of the safety section in clinical study protocols.
  • Review of clinical trial reports/IBs from a safety perspective.
  • Writing the safety parts in the PSUR/PBRER, DSURs, IND, NDA, and other safety documents.
  • Literature search.
  • Electronic reporting to EudraVigilance.
  • Contribution to plans/instructions and SOPs for post-approval surveillance.
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs.
  • Acting as a Project Lead for Safety-only projects.
  • Participation in relevant meetings.
  • Forwarding information to relevant members of the department or study team members.
  • Providing internal support to other relevant departments.
  • Involved in improvement projects with other relevant departments.
  • Active contribution to the organization and development of routines to enhance the work at Tfs Healthscience.
  • Validation of computer applications specific for the department with respect to drug safety requirements.
  • Being well-informed and updated on laws, directives, and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
  • Education and supervision of new Drug Safety personnel.
  • Participation in marketing activities.
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.
  • Understanding of 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.

A Bit More About Us

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

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