Safety Scientist

argenx

4d•Remote

About The Position

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. 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. The Safety Scientist is responsible for the ongoing safety surveillance of assigned investigational and/or marketed products. The safety scientist directs a cross functional team comprised of and Medical Safety, Clinical Development, Regulatory Affairs, Biostatistics, and Safety Operations to ensure timely evaluation of safety data, identification of safety signals, and preparation of high-quality safety deliverables. The Safety Scientist contributes to proactive benefit–risk assessment and compliance with global safety reporting requirements. Effective communication and influence with internal and external stakeholders are essential. This role represents GPS Safety Science internally and externally at a global level and functions.

Requirements

Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
Ability to assemble, analyze and disseminate knowledge gathered from disparate data sources to drive benefit-risk decision making
Knowledge of relevant global pharmacovigilance regulations and guidelines
Ability to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans.
Ability to communicate complex issues effectively
Ability to influence and collaborate with multidisciplinary teams
Ability to prioritize and plan proactively
Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
Experience with MedDRA, WHO Drug Dictionary
Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
Relevant computer skills including proficiency with Microsoft Office
Fluency in written and spoken English
Master’s or doctoral degree in pharmacy, nursing, healthcare or other life sciences or technical fields (MS, PharmD. or PhD)
Minimum of 5-7 years of pharmacovigilance/safety risk management experience

Responsibilities

Conduct continuous review and analysis of aggregate safety data from clinical trials, post-marketing individual case safety reports (ICSRs), literature, registries, and external databases.
Identifies data, analytical, or process improvements that increase the likelihood of detecting a signal or decrease the time to signal detection.
In conjunction with safety physician team members, identifies opportunities to increase knowledge of patient treatment, drugs and interactions, and treatment pathways that drive actions and decisions to ensure the safe use of argenx medicines
Perform medical coding checks, case series reviews, and standardize MedDRA search strategies.
Define data acquisition strategy, methodology, and approach for safety evaluations.
Assist in the assessment and management of medical safety data, and in the development and execution of safety signal and benefit–risk management strategies.
Contribute and perform analysis and participate actively in safety governance meetings, including Safety Management Team (SMT) and Benefit–Risk Committee (BRC).
Lead and participate in the planning, preparation, drafting and review of periodic safety reports, including DSURs, PBRERs/PSURs and PADERs.
Facilitate cross-functional input collection from clinical, nonclinical, regulatory, and statistical teams
Support the end-to-end signal management process and perform signal detection activities through generation of routine outputs and initial trend evaluations using the appropriate tools and methodologies
Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources
Conduct regular literature reviews to identify new safety information related to company products
Assist in the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
Support updates to safety labelling sections and Core Data Sheets (CDS), including reviewing proposed safety language and references
Represent actively safety cross functionally
Support responses to regulatory safety inquiries
Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention
Contribute and collaborate with Clinical, Regulatory, and Biostatistics teams to development and review of clinical documents, including CSRs, IBs, protocols, and SAPs
Provide 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)
Contribute to the maintenance of the safety databases and tools
Participate in cross-functional projects and initiatives
Perform other tasks as required to assist in departmental activities