Global Medical Safety Lead

PURPOSE OF THE FUNCTION

Lead and perform the assessment of medical safety data for assigned products

Develop and execute safety signalling and benefit-risk management strategies

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

REPORTING LINE

Report to the Head of Global Patient Safety

ROLES AND RESPONSIBILITIES

Provide strategic medical safety leadership and practical contributions 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 the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)

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

All other responsibilities as required

SKILLS AND COMPETENCIES

Strong scientific and analytic skills

Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment

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 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.

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 g