Pharmacovigilance Specialist 药物安全/药物警戒 北京

月薪： 1.5千以下/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金

职位描述

职位描述： The China PV Specialist is responsible for safety data management and submission, PV process management, providing training to internal staffs and/or vendors and to be the partner with cross-functional team and external customers.This role should understand company’s code of conducts& compliances policies& China PV Regulations, and to manage the daily activity to align with these accordingly.DUTIES & RESPONSIBILITES1. Fulfilling regulatory requirements and company standards on safety case report processing or case QCKey Tasks: 70% of timea. Individual AE report handling, from all sources: clinical studies, spontaneous, literatures, etc:- Data review, coding, translation and communication- Report to global Data entry site- Report to CFDA- Query answering- Tracking and archiving- Late case communication and CAPA reportb. CFDA batch case handling- Data review, coding, translation or validation- Report to global Data entry site- Query solving- Case synchronizationc. Internal/vendor case QC- Data entry accuracy, integrity and timeliness- Documentation archived completeness and timeliness- Case tracking log accuracy and timeliness- CIOMS download and clean up timely- Global Data entry site queries respond timely- ADR system queries response timely- Late case communication and CAPA report accomplishd. Be back up for team members2. Periodic Safety reports submission or internal deliveryKey Tasks: 10% of timea. Monthly Line Listing submission- Translation validation- Upload to ANGEL- Submission- Tracking and archivingb. Study SUSAR Line Listing- Translation validation- Upload to ANGEL- Submission- Tracking and archivingc.Distribute safety information to study management team and keep tracking.d. PSUR/PBRER submission- Translation validation- Upload to ANGEL- Submission- Tracking and archiving3. Patient Safety quality compliance   Key Tasks: 15% of timea. Monthly AE reconciliation with cross functional team which has interaction on AE reportingb. Carry out QC activities according to internal QM planc. Monthly PSMF preparationd. PV process update and maintenance   4. TrainingKey Tasks: 5% of time· Deliver safety training to ensure full safety compliance- AE awareness training to new staffs- AE awareness training to vendors- Refresh training to the staffs who has stay in the company more than 1 year.   COMPETENCIES Competency- Has an expert knowledge of own technical/scientific area and keeps it up to date.- Understands the regulatory environments in different settings and the drug development process.- Familiar with hospital and clinical operations, broadly understands marketing and sales practice.- Strategic thinking and problem solving skillsFunction specific knowledge- Deeply understand China regulations around drug safety surveillance.- Broadly understand international pharmacovigilance regulations and practices.   Relationship building and networking skills- Creates good impressions with people and proactively builds a network of key contacts (internal and external).- Knows who is important and has good relationship with those people.- Builds trust quickly, listen to other’s points and can talk easily to people from a wide range of backgrounds.   Negotiation and communication skills- Gets points across effectively.- Gets people to do things and communicates complex or unpopular issues clearly.- Is a confident presenter and can adapt a message to fit in with recipient’s needs.- Asks questions to clarify things and can challenge others’ assumptions.   Works Collaboratively- Share information, knowledge and ideas with colleagues.- Accept and support the collective decision, recognize colleagues’ efforts- Express different viewpoints with colleagues in a proper and constructive mannerJob requirementsAcademic / Professional qualificationBachelor degree in medical or pharmaceutical sciences or life sciences requiredPreferably master degree or aboveTechnical / skills trainingChina Regulations on Safety ReportingICH GuidelineGVP guidelineTA Disease knowledgeProduct Safety knowledgeKnowledge in clinical developmentKnowledge in pharmacoepidemiologyWorking experienceAt least 2 years working experiences or graduate from oversea universityLanguage abilityFluent Mandarin and English in reading, writing and speaking 职能类别： 生物工程/生物制药

联系方式

中关村科技园

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

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企业入驻日期： 2017-11-09

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