PURPOSE OF THE FUNCTION
1. Lead and perform the assessment of medical safety data for assigned products
2. Develop and execute safety signaling and benefit-risk management strategies
3. Closely collaborate with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of argenx products
ROLES AND RESPONSIBILITIES
4. Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
5. Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
6. Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
7. Contribute to the development of the overall safety governance structure and activities
8. Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
9. Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
10. Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
11. Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
12. Oversee the medical assessment of individual case safety reports (ICSR)
13. Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)
14. Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
15. Provide medical safety contributions at internal audits and regulatory inspections
16. Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
17. Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
18. Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
19. Participate in cross-functional teams and initiatives
20. All other responsibilities as required
SKILLS AND COMPETENCIES
21. Strong scientific and analytic skills
22. Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
23. Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
24. Excellent presentation skills with the ability to communicate complex issues clearly
25. Relevant computer skills, including proficiency with Microsoft Office
26. Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS
27. MD degree or equivalent required
28. At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
29. At least 1 year of experience in clinical practice or in academic medicine
30. Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
31. Demonstrated ability to perform medical assessments of safety data from multiple sources
32. Experience with authoring complex documents and contributing to regulatory submissions
33. Knowledge of adverse event reporting systems
34. Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.