Safety Specialist药物安全专员 北京

月薪： 1.5-2千/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 01-22 发布
  • 五险一金
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

Purpose:Performs day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings. Essential Functions and Responsibilities:Works independently to receive, triage, manage, and reconcile adverse event reports, including those reported in the scientific literature, in accordance with contractual and regulatory timelines. Manages adverse events and endpoints which may include review of complex medical records, preparation of adverse event narratives and coding of event terms utilizing MedDRA. Assigns preliminary seriousness and labeledness/listedness of event(s). Works within multiple databases. May interact with clients, health care professionals, clinical trial personnel and consumers.Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain medical understanding of applicable therapeutic area and disease states. May participate in oncall duties for specific projects to ensure 24-hr coverage for safety reporting. Performs other duties as assigned.Reviews cases entered for quality, consistency and accuracy, including review of peer reports.Prepares and maintains regulatory safety reports.Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.Job Scope:Pharmacovigilance activities are a key performance measure for clients and PPD. Associated with this position, there is a high degree of liability. Errors made in pharmacovigilance services could affect patient safety, result in the loss of current and/or future contracts, as well as incur regulatory/legal action.Qualifications:Minimum Required Education and Experience:Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experienceOr Life Science degree with 2+ years of clinical experience and 1 year of pharmacovigilance experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the jobRequired Knowledge, Skills and Abilities:General understanding of pathophysiology and the disease processDetailed knowledge of relevant therapeutic areas as required for processing AEsStrong critical thinking and problem solving skillsGood oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesPrevious exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to work effectively within a team to attain a shared goal 职能类别： 药品生产/质量管理 生物工程/生物制药

联系方式

东直门南大街1号来福士大厦

公司信息

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.

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