Pharmacovigilance Specialist 药物安全/药物警戒
科文斯医药研发（上海）有限公司
- 公司规模：1000-5000人
- 公司性质：外资（欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-03-19
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：2年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：0.7-1.4万/月
- 职位类别：药品生产/质量管理
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 & RESPONSIBILITES
1. Fulfilling regulatory requirements and company standards on safety case report processing or case QC
Key Tasks: 70% of time
a. 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 report
b. CFDA batch case handling
- Data review, coding, translation or validation
- Report to global Data entry site
- Query solving
- Case synchronization
c. 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 accomplish
d. Be back up for team members
2. Periodic Safety reports submission or internal delivery
Key Tasks: 10% of time
a. Monthly Line Listing submission
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
b. Study SUSAR Line Listing
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
c.Distribute safety information to study management team and keep tracking.
d. PSUR/PBRER submission
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
3. Patient Safety quality compliance
Key Tasks: 15% of time
a. Monthly AE reconciliation with cross functional team which has interaction on AE reporting
b. Carry out QC activities according to internal QM plan
c. Monthly PSMF preparation
d. PV process update and maintenance
4. Training
Key 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 skills
Function 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 manner
Job requirements
Academic / Professional qualification
Bachelor degree in medical or pharmaceutical sciences or life sciences required
Preferably master degree or above
Technical / skills training
China Regulations on Safety Reporting
ICH Guideline
GVP guideline
TA Disease knowledge
Product Safety knowledge
Knowledge in clinical development
Knowledge in pharmacoepidemiology
Working experience
At least 2 years working experiences or graduate from oversea university
Language ability
Fluent Mandarin and English in reading, writing and speaking
举报
分享
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 & RESPONSIBILITES
1. Fulfilling regulatory requirements and company standards on safety case report processing or case QC
Key Tasks: 70% of time
a. 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 report
b. CFDA batch case handling
- Data review, coding, translation or validation
- Report to global Data entry site
- Query solving
- Case synchronization
c. 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 accomplish
d. Be back up for team members
2. Periodic Safety reports submission or internal delivery
Key Tasks: 10% of time
a. Monthly Line Listing submission
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
b. Study SUSAR Line Listing
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
c.Distribute safety information to study management team and keep tracking.
d. PSUR/PBRER submission
- Translation validation
- Upload to ANGEL
- Submission
- Tracking and archiving
3. Patient Safety quality compliance
Key Tasks: 15% of time
a. Monthly AE reconciliation with cross functional team which has interaction on AE reporting
b. Carry out QC activities according to internal QM plan
c. Monthly PSMF preparation
d. PV process update and maintenance
4. Training
Key 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 skills
Function 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 manner
Job requirements
Academic / Professional qualification
Bachelor degree in medical or pharmaceutical sciences or life sciences required
Preferably master degree or above
Technical / skills training
China Regulations on Safety Reporting
ICH Guideline
GVP guideline
TA Disease knowledge
Product Safety knowledge
Knowledge in clinical development
Knowledge in pharmacoepidemiology
Working experience
At least 2 years working experiences or graduate from oversea university
Language ability
Fluent Mandarin and English in reading, writing and speaking
职能类别： 药品生产/质量管理
关键字： 药物安全 药物警戒 Drug Safety
公司介绍
LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。
欢迎加入科文斯中国团队，我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号，通过移动端迅速查询热招职位并投递申请，与我们并肩实现#CovancePotential。
欢迎加入科文斯中国团队，我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号，通过移动端迅速查询热招职位并投递申请，与我们并肩实现#CovancePotential。
联系方式
- Email：yuanxin.fang@covance.com
- 公司地址：地址：span浦东新区伽利略路338号9号楼