Global Medical Safety Lead

PURPOSE OF THE FUNCTION

The Global Medical Safety Lead is the key point of accountability for ensuring the safety of patients and the safe use of assigned argenx products in development and on-market. The Global Medical Safety Lead leads and performs the assessment of medical safety data and provides strategic medical safety input for the assigned project(s). In this role, the Global Medical Safety Lead is accountable for defining and driving the strategy and approach for the safety activities. Responsibilities include offering expert medical safety contribution and oversight, ensuring comprehensive ownership of safety activities, and leading the assessment of safety data to support informed decision‑making. The role also requires close collaboration with internal stakeholders such as Regulatory Affairs, Clinical Development, and Medical Affairs, as well as external partners including key opinion leaders and regulatory agencies, to align safety communications and ensure the safe and effective use of argenx products.

REPORTING LINE

• Report to the (Asset) Medical Safety Lead

ROLES AND RESPONSIBILITIES

• Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting

• 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)

• 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

• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)

• Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate

• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents

• Oversee the medical assessment of individual case safety reports (ICSR)

• Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)

• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)

• Provide medical safety contributions at internal audits and regulatory inspections

• Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)

• Support adverse event reporting training and pharmacovigilance awareness activities cross functionally

• Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners

• Participate in cross-functional teams and initiatives

• Perform other tasks as required to assist in departmental activities

SKILLS AND COMPETENCIES

• Strong scientific and analytic skills

• Excellent ability to interpret and communicate medical safety data from various sources

• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams

• Excellent presentation skills with the ability to communicate complex issues clearly

• Relevant computer skills, including proficiency with Microsoft Office

• Fluency in written and spoken English

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• MD degree or equivalent required

• 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)

• Experience in clinical practice or in academic medicine is a plus

• 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

Candidates must be located in Belgium, Switzerland or US (EST time zone) to be considered for this role.

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Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.