Clinical Research Specialist

2 days ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time
About this role

We are seeking an experienced Regulatory Compliance Officer to join our team at TFS HealthScience. As a leading global Contract Research Organization (CRO), we partner with biotechnology and pharmaceutical companies in their clinical development journey.

The QPPV/Safety Manager will oversee Drug Safety management according to company policies, SOPs, and regulatory requirements.

Responsibilities:

  1. Holding QPPV responsibilities for some customers.
  2. Acting as a Project Manager for Post marketing Safety-only projects.
  3. Preparing safety parts in PSUR/PBRER, RMP, and other safety documents.
  4. Conducting literature searches.
  5. Handling spontaneous adverse event reports from the market to ensure collection, assessment, and entry into the safety database in accordance with TFS/clients' SOPs and existing demands of authorities.
  6. Reviewing and approving processed cases and AE/SAE reconciliation.
  7. Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
  8. QC and approval of coding of adverse events, medical history, and concomitant medication.
  9. Electronic reporting to EudraVigilance.
  10. Contributing to plans/instructions and SOPs for post-approval surveillance.
  11. Updating templates for safety handling in specific studies/projects according to relevant SOPs.
  12. Participating in relevant meetings and forwarding information to relevant department members.
  13. Providing internal support to other relevant departments.
  14. Involved in improvement projects with other relevant departments.
  15. Actively contributing to the organization and development of routines to enhance the work at TFS.
  16. Validating computer applications specific for the department with respect to drug safety requirements.
  17. Staying informed and updated on laws, directives, and guidelines concerning pharmacovigilance and other safety issues.
  18. Educating and supervising new Drug Safety personnel.
  19. Participating in marketing activities.


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