Risk Management Specialist

9 hours ago

Stockholm, Stockholm, Sweden TN Sweden Full time

At TFS, we're seeking a skilled Risk Management Specialist to join our Project Delivery team.

As a key member of our organization, you will be responsible for the management of drug safety, ensuring that all regulatory requirements and company policies are met.

Responsibilities:

  1. Hold QPPV responsibilities for some customers.
  2. Act as a Project Manager for Post marketing Safety-only projects.
  3. Write the safety parts in the PSUR/PBRER, RMP, and other safety documents.
  4. Conduct literature searches.
  5. Handle spontaneous adverse event reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with TFS/clients' SOPs and existing demands of the authorities.
  6. Review and approve processed cases and AE/SAE reconciliation.
  7. Code adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
  8. Perform QC and approval of coding of adverse events, medical history, and concomitant medication.
  9. Conduct 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 members of the department.
  13. Provide internal support to other relevant departments.
  14. Be 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 well-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.

Qualifications include:

  • A Bachelor's Degree, preferably in life science or nursing; or equivalent.
  • Demonstrable experience working as a QPPV or Deputy QPPV.
  • Ability to work in a fast-paced environment with changing priorities.
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
  • Understanding of the Pharmacovigilance legislation.
  • Ability to work independently as well as in a team matrix organization with little or no supervision.
  • Excellent written and verbal communication skills.

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

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