Medical Safety Lead

argenx SE; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

argenx SE is seeking a Medical Safety Lead to provide strategic leadership in patient safety. This role will involve managing safety signal assessments and cross-functional safety projects.

The ideal candidate will possess an MD and extensive experience in pharmacovigilance along with strong leadership skills. This position offers the flexibility of remote work and an inclusive workplace environment.

Qualifications

• At least 10 years of relevant experience in the pharmaceutical/biotech industry.
• Minimum of 7 years in pharmacovigilance/drug safety.
• Experience in clinical practice or academic medicine is a plus.

Responsibilities

• Lead cross-functional safety signal management and assessments.
• Ensure completeness and quality of safety sections of clinical documents.
• Develop and maintain Risk Management Plans (RMPs) and other safety documents.

Skills

Leadership

Pharmacovigilance knowledge

Analytical skills

Problem-solving skills

Communication skills

Computer proficiency

Collaboration

Education

MD degree or equivalent

Tools

Microsoft Office

Job description

Medical Safety Lead

The Medical Safety Lead provides strategic medical safety leadership, serving as the single point of contact for all aspects of patient safety.

Roles and Responsibilities

• Provide strategic medical safety leadership and practical contributions in a cross‑functional setting.
• Participate in cross‑functional strategic planning and meetings.
• Lead and contribute to the safety signal management and benefit risk assessment activities as well as other regular and/or ad‑hoc aggregate safety data reviews.
• 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, responses to regulatory authority inquiries).
• Contribute to and ensure completeness, accuracy and high‑quality safety sections of clinical documents (including study protocols, IBs, Clinical Study Reports, or ICFs).
• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents.
• Perform the medical assessment of individual case safety reports (ICSR) when required.
• 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 product safety training and pharmacovigilance awareness activities cross‑functionally.
• Lead the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Contribute actively to the updates of the safety labelling sections and Core Data Sheets (CDS).
• Provide strategic guidance and have oversight on the case processing activities.
• Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention.
• Participate in cross‑functional projects and initiatives.
• Manage safety physicians as required.
• Perform other tasks as required to assist in departmental activities.

Skills and Competencies

• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams.
• Knowledge of pharmacovigilance as it applies to safety signal management and safety data review in clinical and post‑marketing settings.
• Knowledge of relevant global pharmacovigilance regulations and guidelines.
• Excellent presentation skills with the ability to communicate complex issues clearly.
• Strong scientific and analytic skills.
• Ability to influence and collaborate with multidisciplinary teams.
• Excellent problem‑solving skills, with sound autonomy and applied judgment.
• 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 10 years of relevant experience in the pharmaceutical/biotech industry with at least 7 years in pharmacovigilance/drug safety (global experience is a plus).
• Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines) and managing complex matrix teams.
• 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.
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.

Work Location

This role is open to remote candidates.

Equal Opportunity Statement

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is a proud equal opportunity employer.