Safety Scientist

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. ROLES AND 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 SKILLS AND COMPETENCIES • 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 EDUCATION, EXPERIENCE AND QUALIFICATIONS • 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 #LI-Remote For applicants in the United States: The annual base salary hiring range for this position is $192,000.00 - $264,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. 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. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. 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.