临床试验患者安全主管
Associate Director, Clinical Trial Patient Safety
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重大影响，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。
职责：
该职位支持临床试验患者安全（CTPS）组织实现其使命，通过一致且准确地交付高质量、相关且及时的数据审查，评估并确保临床试验患者安全数据的质量。创建流程改进、员工发展、绩效衡量、项目优先级设定的文化，并开发/实施成功的解决方案，带领CTPS团队，将业务愿景转化为广泛且可操作的战略。
职责：
该职位负责全球临床试验患者安全数据的监测，包括组织、资源配置和持续改进工作。支持CTPS总监。
核心职责包括：
• 管理指定的运营区域/与化合物相关的临床研究及相关系统，确保临床安全不良事件监测以合规且及时的方式进行，在检查准备就绪的环境中满足质量输出要求。
• 建立、监控、评估并沟通运营区域的工作量预测和指标。
• 支持部门和分部的培训计划，持续的知识获取和员工发展，通过有效识别部门和分部的需求，并成功向管理层提出。
• 创建并维持一个吸引、培养和留住优秀科研人员的环境。制定并开展积极的人才管理。
• 协助管理层进行战略规划和部门发展。为各自团队或CTPS计划开发并参与特别项目。
• 将对ICH、FDA、EMA法规和指南的高级知识应用于所负责的工作，这些法规和指南影响药物安全问题，进而影响CTPS流程、程序和全球报告要求。
• 与治疗领域医学博士/医学监查员合作，提供医学安全审查的监督
查看英文原文
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.
Purpose:
This position supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of
evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery
of high-quality, relevant and timely data review. To create a culture of process improvement, employee
development, performance measures, project prioritization, and to develop/implement successful
solutions leading the CTPS team, translating the business vision into broad and actionable strategies.
Responsibilities:
This position is responsible for world-wide surveillance of clinical trial patient safety data, including
organization, resourcing and continuous improvement efforts. Supports Director of CTPS.
Core Job Responsibilities include:
• Manages assigned operational area(s)compound associated clinical studies and related systems to
ensure clinical safety adverse event surveillance is managed in a compliant and timely manner
meeting quality outputs within an inspection-ready environment.
• Establish, monitor, evaluate, and communicate workload projections and metrics for operational
area(s).
• Supports department and divisional training programs, ongoing knowledge attainment, and
development of staff by effectively identifying department and division needs and successfully
presenting them to management.
• Creates and sustains an environment that attracts, develops, and retains talented scientific
professionals. Plans and conducts active talent management.
• Assist management with strategic planning and department development. Develop and participate in
special projects for respective teams or CTPS initiatives.
• Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues
to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting
requirements.
• Partner with therapeutic area MDs/medical monitors to provide oversight of medical safety review at
the compound study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, etc.
• Provide oversight of narrative deliverables, issue management, document management systems, and
centralized data review for assigned compound associated clinical studies. Effectively
communicates/escalates relevant study and/or team-related information to appropriate clinical team
members and/or management.
• Understands, implements and improves department SOPs as part of continuous improvement,
including implementation of new regulatory requirements.
• Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts.
Provides perspective, insight and benchmark information and approaches for business-related initiatives.
• Manages 5 to 10 people.
- Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 10 years of experience in clinical research in the pharmaceutical industry.
- Project management experience with cross-functional projects. Knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
- Experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations. Understanding tools, standards and approaches to efficiently evaluate drug safety.
- Demonstrated effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change.
- Leadership and communication skills that minimally include: effective and timely communication of project objectives, issues/risks and other project information required to keep the team and management informed.
- Demonstrated sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams.
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 long-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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html