PURPOSE OF THE FUNCTION
1. Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region.
2. Assess current processes to ensure adherence to local/regional safety regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with global standards.
Preferred locations: Belgium, Switzerland
ROLES AND RESPONSIBILITIES:
3. Act as point of contact for pharmacovigilance in the assigned country/region.
4. Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable
5. Support the Head of Regional PV in the harmonization of processes across the regions
6. Support the Head of Regional PV in the management of innovation projects for increasing Regional Team efficiency.
7. Establish and maintain the applicable pharmacovigilance system specific to the country/region
8. Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
9. Provide support to responses to local pharmacovigilance related regulatory requests.
10. Communicate global procedures and practices and monitor implementation.
11. Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments
12. In collaboration with the Regional PV Head, the GPS Ops and GPS QM Teams, review the documentation related to the concerned outsourced activities.
13. Lead the PSMF data collection in the country/region when needed.
14. Review documents pertinent to Non interventional studies and other organized data collection (Patient support programs and Market researches included), where applicable.
15. Manage activities related to the proper intake and monitoring of unsolicited sources of safety information (eg, medical enquires, quality complaints, legal claims, social media posts) in the assigned country/region.
16. Increase the visibility of the GPS team/function throughout argenx with focus on region.
17. Participate in health authority interactions throughout the product life-cycle as needed.
18. Closely collaborate with other functions including regulatory, medical, marketing, commercial, communications, quality, legal, as well as other teams as needed.
19. Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements.
20. Develop relationships with cross functional teams and with business partners as it relates to adverse event reporting and other pharmacovigilance activities.
21. Maintain an in-depth knowledge of local regulations, expectations and perform activities related to the interpretation and review of existing and evolving safety requirements.
22. Identify, assess and communicate both internally and externally to GPS, all pharmacovigilance legislations updates that can impact the global GPS function and/or the Company overall (Pharmacovigilance intelligence).
23. Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
24. Contribute to GPS issue management, recommend and implement action plans for mitigation.
25. Identify opportunities to align PV standards globally.
26. Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
27. Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the country/region.
28. Transparently communicate and/or escalate issues to GPS leadership as appropriate.
29. Drive Continuous Improvement initiatives as needed.
30. May perform other tasks as appropriate.
SKILLS AND COMPETENCIES:
31. Excellent presentation skills with the ability to communicate complex issues clearly
32. Excellent planning and organizational skills with ability to manage competing priorities
33. Excellent oral and written communication skills
34. Strong ability to motivate, influence, and collaborate with multidisciplinary teams
35. Ability to work independently and in a global environment
36. Understanding of safety business processes and systems for the collections of adverse events
37. Problem solving, conflict resolution and critical thinking skills
38. Demonstrated ability to author or contribute to complex documents
39. Relevant computer skills, including proficiency with Microsoft Office Suite
40. Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
41. Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
42. At least 8-13 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 7 years in pharmacovigilance/drug safety
43. Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
44. Knowledge of the drug development process, GXP quality and compliance requirements