Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Global Medical Safety lead

Purpose of the Function:

Lead and perform the assessment of medical safety data for assigned productsDevelop and execute safety signaling and benefit-risk management strategiesClosely 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:

Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional settingPerform 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 activitiesProvide 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 accurateLead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documentsOversee the medical assessment of individual case safety reports (ICSR)Confirm criteria and content for expedited reporting and unbinding (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 inspectionsSupport 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 functionallySupport the preparation of pharmacovigilance agreements with clinical development or commercial business partnersParticipate in cross-functional teams and initiatives

Skills and Competencies:

Strong scientific and analytic skillsAbility to complete multiple tasks concurrently and deliver results in a fast-paced environmentStrong ability to lead, motivate, influence, and collaborate with multidisciplinary teamsExcellent presentation skills with the ability to communicate complex issues clearlyRelevant computer skills, including proficiency with Microsoft Office

Education, Experience and Qualifications:

MD degree or equivalent requiredAt 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)At least 1 year of experience in clinical practice or in academic medicineWorking knowledge of relevant pharmacovigilance regulatory requirements and guidance documentsDemonstrated ability to perform medical assessments of safety data from multiple sourcesExperience with authoring complex documents and contributing to regulatory submissionsKnowledge of adverse event reporting systemsExperience in epidemiology, biostatistics, clinical development, or medical affairs is a plus