Ensure the argenx PV System Pharmacovigilance System Master File(s) is consistent and compliant with all the regulatory requirements worldwide in terms of structure and content.
In case of official request, ensure the timely and compliant PSMF submission to any relevant Health Authority.
ROLES AND RESPONSIBILITIES:
1. Keep the GPS Regional PV Head and the EU/UK QPPV informed at any step of the PSMF process and immediately inform them in case of any issue related to the PSMF update.
2. Ensure that the Company Summary of Pharmacovigilance System is maintained, updated, and track its submission.
3. Lead the European PSMF data collection worldwide.
4. Manage local PSMFs and other local PV System Sub-Files (PSSFs) in collaboration with relevant Local PV responsible persons at both argenx and Business Partners side.
5. Support the Head of Regional PV in the management of innovation projects for increasing PSMF data collection efficiency.
6. Continuously promote awareness of PSMF within argenx.
7. Maintain the PSMF Calendar and RACI and keep it continuously updated.
8. Train new and/or identified PSMF contributors
9. Support effort of Increasing the visibility of the GPS team/function within argenx.
10. Maintain an in depth knowledge of global and local PSMF requirements to fulfill applicable regulations.
11. Contribute to the development and evaluation of PSMF process compliance metrics.
12. Lead PSMF process improvement projects
13. Support and participate in GPS audits and inspections, as needed.
14. Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
15. Transparently communicate and/or escalate issues to GPS leadership as appropriate.
16. Coordinate Continuous Improvement initiatives when assigned.
17. Perform other tasks as assigned by line manager or Head of GPS.
SKILLS AND COMPETENCIES
18. Good presentation skills with the ability to communicate complex issues clearly
19. Very Good planning and organizational skills with ability to manage competing priorities
20. Excellent oral and written communication skills in English
21. Strong ability to motivate, influence, and collaborate with multidisciplinary teams
22. Ability to work independently and in a global environment
23. Understanding of safety business processes and systems for the collections of adverse events
24. Problem solving, conflict resolution and critical thinking skills
25. Demonstrated ability to author or contribute to complex documents
26. Relevant computer skills, including proficiency with Microsoft Office Suite
27. Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS
28. Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field.
29. At least 7-12 years of experience in the pharmaceutical/biotech industry or a CRO with at least 5 years in pharmacovigilance/drug safety.
30. Either Project Management experience or earlier experience in managing PSMF required.
31. Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
32. Basic understanding of the drug development process, GXP quality and compliance requirements.