高级临床安全分析师
Senior, Clinical Safety Analyst
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，解决当前严重的健康问题，并应对未来的医疗挑战。我们致力于在多个关键治疗领域产生显著影响，包括免疫学、肿瘤学和神经科学——以及我们Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
高级临床安全分析师独立审查来自临床试验的安全相关数据，确保内容完整、质量合格、符合监管指南和方案要求，通过收集、分析和分类不良事件，该职位对产品审批、安全信号识别和患者安全产生影响。
职责
· 参与指定产品的相关安全监测活动；并在需要时参与临时安全报告的规划和完成。
· 及时评估不良事件编码的一致性和准确性；准确有效地进行安全相关CRF和实验室数据的医学审查，并通过与研究指定医生沟通，与研究经理、临床研究组织、临床研究助理、数据管理、药物警戒等人员协作，确保查询解决。
· 监督对研究人员的安全相关查询的跟踪，并协助处理IRB/IEC的安全问题。
· 协助制定和实施研究安全审查计划，与研究指定医生合作，并根据需要向临床团队成员、临床研究组织、研究人员和研究站点提供安全概述；审查研究方案、IND报告、年度报告、研究者手册、临床报告的安全部分、监查计划、IDMC数据和其他包含安全数据的临时报告。
· 根据公认的标准，撰写严重不良事件和其他感兴趣事件的叙述，具备高度的专业能力。
· 运用对ICH、FDA、EMA法规和指南的知识，理解影响药物和疾病状态的问题，深入掌握产品标签/文献，包括安全特性。理解、实施并改进部门SOP。具备临床知识，用于不良事件数据的收集和评估。
· 可能需要…
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
The Senior Clinical Safety Analyst independently reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols by collecting, analyzing, and triaging Adverse Events as this position impacts product approval, safety signal identification, and patient safety.
Responsibilities
· Participates in applicable safety surveillance activities for assigned products; and in planning and completion of Ad-Hoc Safety Reports as needed.
· Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.
· Supervise tracking of safety -related queries to Investigators and assists in handling safety questions from IRB/IEC.
· Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.
· Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.
· Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.
· May serve as a representative for Safety Management on cross-functional projects, but does not assume decision-making responsibilities in the representative role; Contacts may include Clinical Safety Manager and a variety of multidisciplinary representatives (e.g. Regulatory Affairs, Quality Assurance, Compliance).
· Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction
· Workload responsibilities are primarily study-related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager.
· Starts to mentor/teach others with directions from lead mentor or team manager. Assists in mentoring staff by coaching and mentoring designated Safety staff on assigned safety activities.
- Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
- Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience.
- Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases).
- Ability to critically evaluate medical data.
- Ability in accurately and medically presenting; of case data, both orally and in writing.
- Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence.
- Monitor problems through resolution.
- Analyze and interpret adverse event data as a component of clinical surveillance activity.
- Consistently exercise good judgment within policies and regulations.
- Effective communication skills in delivering study-related information.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
· The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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