Global Safety Lead

PURPOSE OF THE FUNCTION

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

• Develop and execute safety signaling 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

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 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 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.