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(高級)藥物警戒專員-第三方員工
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職位描述
Talent@Boehringer Ingelheim
About Boehringer Ingelheim
JoinBoehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and havecollaborated and innovated medicinesin Human Pharma, Animal Health and Biopharmaceuticaleverywhere in the worldfor over 130 years.This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations. We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve BI global Ambition 2025: ?No. 1 in Animal Health
? No. 1 in Biopharmaceutical Contract Manufacturing
?No. 1 in value share for our brands in One Human Pharma
As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 5 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa. For more information, please
1.visithttps://www.boehringer-ingelheim.com/or
2.follow us on LinkedIn, or
3.follow us on WeChat – JoinBI
About Human Pharmaceutical Business
With global presence,Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. Our innovative medicines include those for COPD, hypertension, stroke, atrial fibrillation-related stroke prevention, Parkinson’s disease, diabetes and non-small cell lung cancer. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients. This vision is supported by industry-leading levels of investment. This includes more than a hundred R&D pipeline projects, around 50% of early- to mid-stage pipeline anchored in external innovation (2016), and around 20% of net revenue invested in R&D (2016) at a global level. Meanwhile, as one of the Company’s strategic pillars in China, Research Beyond Borders (RBB) explores emerging science, indications and technologies to expand R&D opportunities in China, and even the entire Asia.
Job Responsibilities
AE collection and processing:
- Process all AEs from all sources in compliance with global and local requirements.
- Be responsible for follow up activities according to BI SOPs.
- All AE reports shall be properly documented and tracked.
PV regulatory submission:
- Submit individual and aggregate safety report to local health authorities as required.
- Timely prepare and submit local PSUR to HA according to local processes and regulatory requirements.
Literature screening and processing:
- Review and QC of screening results according to global/local requirements.
- Timely process all ICSRs and PV-relevant information from literature source.
AE reconciliation:
- Conduct regular AE reconciliation with MI/QA/Communication.
- CRM database monitor and process identified cases.
PV report distribution:
- Distribute safety reports from GPV to the relevant team (eg: CO, GDM) for further distribution to investigators.
AE reporting training:
- Work together with HR to provide the AE reporting training to new employees.
- Provide the advance AE reporting training to key stakeholders who may easily receive safety information.
Other tasks as assigned by line manager.
Qualifications
- Education/Degree Requirements:Bachelor degree or above
- Major:Medical or pharmaceutical or bioscience graduate
- Language skills & proficiency:Good command of written and verbal English
- Required capabilities (skills, experience, competencies): able to work effectively as part of a team; ability to work independently, guided by procedures, with appropriate support; self-management with goals and objectives; organized at work, with clear goals and priorities; good communication with coworkers, managers and customers; good presentation skill: able to deliver information clearly; Atleast2years working experience ininternationalpharmaceutical industry, preferred inPV working area.
Behaviours
- Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions
- Agility –Quicklyact with an open mind to face internal and external transformation
- Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets
Contact Us If you think you can convince us that you are the right candidate we are looking for, apply now!
企業簡介
世界知名的勃林格殷格翰集團已有120年的歷史,業績出色。集團總部設在德國殷格翰,全球范圍內,公司在100多個國家和地區擁有進行研究開發、生產和銷售的機構。 1994年勃林格殷格翰集團進入中國, 上海勃林格殷格翰藥業有限公司是其在華投資的高新技術企業之一, 業務集中于人體處方藥,一直以來公司各系統方面的研究功譽卓著。公司各種產品在全世界范圍內得到一致好評,近些年來產品銷量一直穩居世界前列。
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上海勃林格殷格翰藥業有限公司
企業性質:外資企業
企業規模:100-499人
成立年份:1995
企業網址:http://www.boehringer-ingelheim.com.cn
企業地址:浦東大道138永華大廈22層
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職位發布日期: 2019-04-04