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Drug Safety Associate/ Drug Safety Officer

 
岗位信息
  • 更新时间:2016-02-29
  • 学历:本科
  • 工作地点:北京市
  • 语言要求:英语
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:
岗位要求
岗位职责:



JOB SUMMARY
The primary responsibility of the Drug Safety Associate/ Drug Safety Officer 〔DSA/DSO) is to receive, assess, interpret and co-ordinate Adverse Event 〔AE) data generated from spontaneous and clinical trial data or other source, in compliance to local and international regulatory requirements and Pfizer corporate guidelines.
The DSA /DSO should interact with several groups of individuals 〔external and internal) to fulfill their responsibilities. The external groups consist of healthcare professionals, caregivers and patients, or regulatory authority. The internal groups may consist of Regulatory Affairs, Sales and Marketing, Regional and Pfizer Global Pharmacovigilance Office.


KEY RESULT AREAS &; JOB ACTIVITIES /TASKS
1. Safety Reporting
- In response to written or verbal information received, 〔either directly or from other Medical professionals, for example, from product physicians or Medical Information Communication Specialist, MICS), identity and attempt to gather additional information on spontaneous AE reports and SAEs from clinical trials or other solicited source
- Enter the data and process the individual case safety report in Official Safety Database according to standards to ensure the accurate and complete reporting of safety information
- Complete the AE report as per local regulatory requirement accordingly
- Ensure all AE report/data is entered into the local AE tracking system in an accurate, complete and timely manner
- Liaise with reporters of AEs to ensure there is adequate follow-up of all AE reports to resolution or stabilization in accordance with Pfizer guidelines for follow-up
- Identity AEs reported in locally published literature and forward to SRM as appropriate
- Maintain a current awareness of regulatory development, both locally and internationally to ensure Pfizer is addressing relevant requirements
- Involved in the preparation of Line Listing submission to the regulatory authority as required
- Ensure the timely, complete and accurate filing of all safety information in the local AE filing system
2. Other Business Support from drug safety aspect
- Provide relevant product safety information to support price bidding, license renew, or other special project as appropriate
- Involved in the development, implement, maintain and monitor local office management documents as needed
- Provide support to audit/inspection activities as appropriate


EDUCATION &; EXPERIENCE REQUIREMENTS
1. Educational /Training
- Educational: Bachelor or above, Medical background is preferred
2. Working Experiences
- Experience in clinical practice/pharmacovigiliance field in industry is preferred
- Experience in any aspects of drug information
- Experience in any therapeutic areas
COMPETENCIES REQUIREMENTS
1. Ability Functional
- Proficiency Basic Microsoft Word, PowerPoint, Excel
- Fluent English Reading and writing
2. Cultural Competencies 〔Leadership Behaviors)
- Sustain Focus on Performance
- Create an Inclusive Environment
- Encourage Open Discussion and Debate
- Manage Change
- Develop People
- Align Across Pfizer


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