argenx
Medical Safety Lead
United States - Remote
Sponsorship not specified$292k-$402kDetected 28 days ago
Computer VisionFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationProblem SolvingMicrosoft OfficeBiostatisticsEpidemiologyRegulatory Affairs
About the role
- This range reflects our good faith estimate at the time of posting.
- This means actual pay may differ from the posted range when justified by these factors.
- Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
Responsibilities
- 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)
- Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
- Support product(s) 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)
- Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
- In this role, the Lead is accountable for defining and driving the strategy and approach for communicating safety information across the product(s) lifecycle and projects.
- Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention
Requirements
- MD degree or equivalent required
- 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 with authoring complex documents and contributing to regulatory submissions
- Knowledge of adverse event reporting systems
- Manage safety physicians as required
- Perform other tasks as required to assist in departmental activities
- Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
- Demonstrated ability to perform medical assessments of safety data from multiple sources
- Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus
Nice to have
- 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)
- Experience in clinical practice or in academic medicine is a plus
Skills
- Knowledge of pharmacovigilance as applies to safety signal management, 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
Compensation
- The annual base salary hiring range for this position is $292,000.00 - $401,500.00 USD.
Benefits
- Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity.
- It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
- 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.
- Provide strategic medical safety leadership and practical contributions in a cross-functional setting
- 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
- 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
- The Medical Safety Lead provides strategic medical safety leadership, serving as the single point of contact for all aspects of patient safety.
Company info
- We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business.
- We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
Equal opportunity
- If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com.
- Only inquiries related to an accommodation request will receive a response.
This listing is sourced directly from argenx's careers page and normalized into a canonical job model.