Safety and Risk Manager

2 days ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time
About the Role

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies in their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and functional service solutions.

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

Main Responsibilities:

  1. Hold QPPV responsibilities for some customers.
  2. Act as a Project Manager for Post marketing Safety-only projects.
  3. Write safety parts in PSUR/PBRER, RMP, and other safety documents.
  4. Conduct literature searches.
  5. Handle 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. Review and approve 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. Contribute to plans/instructions and SOPs for post-approval surveillance.
  11. Update templates for safety handling in specific studies/projects according to relevant SOPs.
  12. Participate in relevant meetings and forward information to relevant department members.
  13. Provide internal support to other relevant departments.
  14. Involved in improvement projects with other relevant departments.
  15. Actively contribute to the organization and development of routines to enhance the work at TFS.
  16. Validate computer applications specific for the department with respect to drug safety requirements.
  17. Stay informed and updated on laws, directives, and guidelines concerning pharmacovigilance and other safety issues.
  18. Educate and supervise new Drug Safety personnel.
  19. Participate in marketing activities.


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