Global Medical Safety Lead — Pharmacovigilance & Signals

argenx BV; Belgique; Remote; EUR 140,000 - 200,000; Full time

Job summary

argenx, a global immunology company, is seeking a senior medical safety leader to oversee safety assessments and risk-management for its diverse portfolio.

Reporting to the Head of Global Patient Safety, you will collaborate with Regulatory Affairs, clinical development, and medical affairs to align safety communications, prepare regulatory safety sections, and drive governance of pharmacovigilance activities worldwide.

Qualifications

• MD degree or equivalent required.
• At least 15 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus).
• At least 1 year of experience in clinical practice or in academic medicine.
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents.
• Demonstrated ability to perform medical assessments of safety data from multiple sources.
• Experience with authoring complex documents and contributing to regulatory submissions.
• Knowledge of adverse event reporting systems.
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.

Responsibilities

• Provide strategic medical safety leadership for assigned product(s) in a cross-functional setting.
• 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).
• Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s).
• Contribute to the development of the overall safety governance structure and activities.
• Provide safety strategies and deliver accurate, timely and high quality safety contributions for regulatory submissions (ISS, SCS, narratives).
• Prepare and/or review safety sections of clinical/regulatory documents (study protocols, IBs, Clinical Study Reports, or ICFs).
• Provide medical safety support for responses to regulatory authority inquiries; ensure safety information is timely and accurate.
• Lead the preparation of periodic safety reports (PSUR, DSUR) and ensure consistency and quality of these documents.
• Oversee medical assessment of individual case safety reports (ICSR).
• Confirm criteria and content for expedited reporting and unblinding (SUSARs).
• Lead or contribute to safety presentations to the Data Safety Monitoring Board (DSMB).
• Provide medical safety contributions at internal audits and regulatory inspections.
• Support GPS SOPs and other controlled documents; participate in cross-functional initiatives.

Skills

Scientific skills

Analytical thinking

Cross-functional leadership

Presentation skills

MS Office

English fluency

Education

MD degree

Job description

argenx, a global immunology company, is seeking a senior medical safety leader to oversee safety assessments and risk-management for its diverse portfolio.

Reporting to the Head of Global Patient Safety, you will collaborate with Regulatory Affairs, clinical development, and medical affairs to align safety communications, prepare regulatory safety sections, and drive governance of pharmacovigilance activities worldwide.