Drug Safety Specialist jobs at Ge Healthcare in China, Shanghai

• Intake of emails in shared mailbox and book-in and triage of certain types of safety reports in GAED in accordance with GPV processes and global regulatory requirements and guidelines, ensuring accurate and timely handling.
• Perform data entry and quality review of certain types of safety reports in GAED, including coding of MedDRA terms and preparation of case narratives to ensure the accuracy, consistency and compliance.
• Conduct follow-up activities, including generating and sending out follow-up letters and closing action items in GAED according to company SOPs.
• Interface with internal stakeholders for issues/ requests and escalate as appropriate.
• Ensure archiving of safety data in accordance with regulatory requirement and company SOPs.
• Ensure availability of current organization charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s).
• Conduct Regulatory Intelligence tasks according to instruction.
• Develop knowledge for pharmacovigilance regulations, guidelines and company SOPs and conventions.
• Any other tasks assigned by line manager.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

角色与职责

• 领导和监督业务运营的非律师人员，以确保遵守内部公司和外部监管合规的所有规定。确保建立适当机制，以遵守相关法律法规，并遵守公司计划和实践。
• 深入了解一门学科。利用先前的经验和获得的专业知识来执行职能政策/策略。
• 深入理解关键业务驱动力；用这种理解来完成自己的工作。深入了解自己团队的工作如何与其他团队融合并为该领域做出贡献。
• 利用技术专长和判断力来解决问题。利用解决问题所需的技术技能和分析思维。可以使用自己团队以外的多个内部资源来做出决定。
• 此级别的职位可能由个人贡献者担任，且其具有成熟的人际交往能力。向直接相关的同事和业务部门传达所提供的设计和协调服务。为新团队成员提供非正式指导。在简单的情况下向其他人解释复杂的信息。

基本资格

• 该岗位要求在领域具有较丰富的工作经验。学力水平相当于从正规高等院校取得学士学位 （或根据相应工作经验具有高中学历）

所需特性

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Conduct comprehensive analysis of financial statements, including the income statement, to identify trends, variances, and key drivers of profitability.
• Provide actionable and strategic insights to support business decisions and enhance overall financial performance.• Focus on expense control and cost-saving initiatives across the organization.
• Identify opportunities to optimize resource allocation and promote a cost-saving culture.
• Implement strategies to monitor and manage expenses effectively.

• Review and identify areas for improvement of existing process and rules, and implement changes to enhance overall financial operations.• Monitor and manage cash flow to ensure liquidity and minimize financial risks.
• Oversee Accounts Receivable (AR) to maintain a healthy working capital position.• Provide financial support to the commercial team, including analysis related to pricing and rebates as needed.• Participate in the financial closing process, ensuring accuracy and compliance with accounting standards.
• Contribute to the annual budgeting process and provide regular financial reporting.• Support the adoption of digital tools and technologies (e.g., Power BI, AI) to streamline financial processes and enhance efficiency.
• Drive initiatives to automate financial tasks and improve data visualization.

• Strong analytical skills with the ability to interpret complex financial data.
• Experience in expense management and financial analysis.
• Proficiency in financial software and tools, including Excel, Power BI, and ERP systems.
• Knowledge of accounting principles and financial reporting standards.
• Ability to work collaboratively across teams and support strategic initiatives.
• Familiarity with digital transformation tools and a willingness to innovate.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Job Description

• Intake, triage and process of adverse event and medical device reports from all sources including post-marketing, clinical trials, and published literature, ensuring accurate and timely handling.
• Perform initial assessment of seriousness, expectedness, causality, reportability, timeline and special scenarios, in accordance with GPV processes and global regulatory requirements and guidelines.
• Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives to ensure the accuracy, consistency and compliance.
• Identify missing or discrepant case information and determine and conduct appropriate follow-up activities.
• Perform reconciliations between clinical, quality and PV databases.
• Prepare expedited reports for submission to regulatory authorities and ethics committees.
• Interface with internal stakeholders for issues/ requests (e.g. with Quality Assurance for product issues or complaints, with legal for litigation or claims) and escalate as appropriate.
• Serve as pharmacovigilance liaison and resource to internal and external groups (e.g. Regulatory Affairs, Medical Affairs, Clinical Development teams, CROs, etc.) on issues related to case processing.
• Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed.
• Support preparation and submission of aggregate reports including PSURs, DSURs, and PBRERs, as needed.
• Serve as pharmacovigilance resource during inspections and audits.
• Act as liaison between China LSU and global case processing teams to address domestic case related issues.
• Provide pharmacovigilance trainings to local staffs and business partners upon request.
• Support local response to safety related requests from local Health authority upon request.
• Add Chinese translation for domestic cases in GAED to allow for E2b R3 reporting to NMPA upon request.
• Ensure archiving of safety data in accordance with regulatory requirement and company SOPs.
• Ensure availability of current organization charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s).
• Develop expertized knowledge for pharmacovigilance regulations, guidelines and company SOPs and conventions.
• Any other tasks assigned by line manager.

Qualifications and Requirements:

• Bachelor’s degree or above, major in medicine, pharmacy, epidemiology or related major
• 1-2 years of pharmaceutical/biotechnology industry experience in case processing.
• Safety database user experience
• Familiar with global and local PV regulations and guidelines pertaining to collection, processing and reporting of adverse event
• Computer literacy (e.g. Microsoft Office software)
• Fluency in spoken and written English
• Shall be willing to submit to a background investigation, including for example, verification of past employment, criminal history, and educational background.

Desired Characteristics:

• Sound attention to detail
• High integrity, sense of urgency, ability to recognize time sensitivity
• Argus user experience preferred
• Ability to identify and solve routine problems independently
• Ability to manage multiple priorities
• Competent communication skills and able to communicate effectively in a matrix environment.
• Being open to change (positive or negative) in response to new information, different or unexpected circumstances.
• Health Care Professional experience preferred

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Roles and Responsibilities

• Handle deviation/OOS/CAPA to ensure deviations are reviewed, assessed, evaluated to comply with the cGMP. Collaborate and work together with other departments to allow closure of preventive and corrective actions and ensuring the overall smooth running of the deviation system.
• Handle product complaints to ensure that customer complaints are investigated, and documented appropriately according to procedures, well communicate response with sales or hospitals.
• Lead cross-department project to ensure project smoothly running against schedule.
• Liaise with Operations personnel to ensure regulatory and quality requirements are met during routine operations.
• Monitor the manufacturing process/documentation/computerized system to meet with procedure, GMP and data integrity requirements.
• Monitor and aid the implementation of continuous improvements and process changes.
• Take part in internal and external audit, be responsible for audit response and implementing improvement.
• Coordinate QA activities including deviation/OOS/complaint management, revision of SOPs, QA routine tasks and new projects.
• Review of batch manufacturing records and the process of manufacture, make the decision to release/reject the product in compliance with all licenses and GMP requirements.

Required Qualifications

• B.S. Degree in technical field, better major in pharmacy, food science, chemistry etc.
• Minimum 5-year experience in pharmaceutical industry or a medical device. Personnel with work experience in QA or QC will be preferred.
• ​Thorough knowledge of national and international GMP requirements.
• Fluent English in speaking, listening, reading and writing.
• Proficiency in Microsoft Office Suite.

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

Inclusive & Diversity Paragraph

• GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behavior Statement

• We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Total Reward Statement

• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.