Pharmacovigilance Supervisor 药物警戒主管
博士伦
- 公司规模：1000-5000人
- 公司性质：合资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-06-20
- 工作地点：上海
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 职位类别：生物工程/生物制药 其他
职位描述
OBJECTIVE
In collaboration with the Global Pharmacovigilance (GPV) staff and MA Director of China, to set up and maintain an efficient Pharmacovigilance (PV) system in compliance with the national regulations for drugs and biologics and with the B+L PV procedures.
RESPONSIBILITIES
1. AE Processing
- Collect, process and follow up all local adverse events (AEs) from different sources (Healthcare professionals, sales and marketing personnel, patients, etc.);
- Report the AEs to the Health Authority (HA) according to the Chinese regulation within the required timeframe and answer any subsequent questions in collaboration with MA staff and the GPV;
- Transmit all local adverse events reports to GPV within the required timeframe; answer the queries of the GPV using specific questionnaires provided by GPV when applicable;
- Answer the safety questions from the Health Care Professionals with the support of MA staff, GPV, if necessary;
- Archive all source documentation in accordance with Quality Control;
- File all Pharmacovigilance source documents and keep them available on request by the HA.
2. Studies activities
- Review protocols for clinical trials sponsored by B+L, in order to ensure compliance with the pharmacovigilance requirements;
- Keep updated a table summarizing all clinical trials/ observational studies on-going in the countries, following information provided by the country for the local projects and information provided by GPV for others;
- Submit the Serious Adverse Events, unexpected events to HA according to the national regulations.
3. PSURs
- Prepare the local annual AE summary in collaboration with MA team, the local Regulatory Affairs and GPV; send it to the HA according to the pharmacovigilance regulatory requirements;
- Submit individual PSURs released by the GPV to HA;
- Forward any assessment report or question received from authorities to both the GPV and the regional coordinator, and coordinate any response to authorities with them.
4. Pharmacovigilance Indicators
- Provide the GPV with the monthly summary of compliance indicators for Pharmacovigilance reports processed locally.
5. Risk Management
- Provide professional inputs in risk management
6. PV training
- Provide regular Pharmacovigilance training to all B+L China staffs.
REQUIREMENT
1. University graduate with Medical, or Pharmacist background.
2. At least 1-2 years working experience in drug safety field.
3. Previous working experience in MNC pharmaceutical company or CRO company is a plus.
4. Be familiar with the relevant regulations
5. Fluency in English (oral and written) is essential
6. Good project management skill
7. Superior interpersonal and communication skill
8. Good training skill
9. Responsible, professional, detail oriented and with patience
10.Flexible and works well in team
In collaboration with the Global Pharmacovigilance (GPV) staff and MA Director of China, to set up and maintain an efficient Pharmacovigilance (PV) system in compliance with the national regulations for drugs and biologics and with the B+L PV procedures.
RESPONSIBILITIES
1. AE Processing
- Collect, process and follow up all local adverse events (AEs) from different sources (Healthcare professionals, sales and marketing personnel, patients, etc.);
- Report the AEs to the Health Authority (HA) according to the Chinese regulation within the required timeframe and answer any subsequent questions in collaboration with MA staff and the GPV;
- Transmit all local adverse events reports to GPV within the required timeframe; answer the queries of the GPV using specific questionnaires provided by GPV when applicable;
- Answer the safety questions from the Health Care Professionals with the support of MA staff, GPV, if necessary;
- Archive all source documentation in accordance with Quality Control;
- File all Pharmacovigilance source documents and keep them available on request by the HA.
2. Studies activities
- Review protocols for clinical trials sponsored by B+L, in order to ensure compliance with the pharmacovigilance requirements;
- Keep updated a table summarizing all clinical trials/ observational studies on-going in the countries, following information provided by the country for the local projects and information provided by GPV for others;
- Submit the Serious Adverse Events, unexpected events to HA according to the national regulations.
3. PSURs
- Prepare the local annual AE summary in collaboration with MA team, the local Regulatory Affairs and GPV; send it to the HA according to the pharmacovigilance regulatory requirements;
- Submit individual PSURs released by the GPV to HA;
- Forward any assessment report or question received from authorities to both the GPV and the regional coordinator, and coordinate any response to authorities with them.
4. Pharmacovigilance Indicators
- Provide the GPV with the monthly summary of compliance indicators for Pharmacovigilance reports processed locally.
5. Risk Management
- Provide professional inputs in risk management
6. PV training
- Provide regular Pharmacovigilance training to all B+L China staffs.
REQUIREMENT
1. University graduate with Medical, or Pharmacist background.
2. At least 1-2 years working experience in drug safety field.
3. Previous working experience in MNC pharmaceutical company or CRO company is a plus.
4. Be familiar with the relevant regulations
5. Fluency in English (oral and written) is essential
6. Good project management skill
7. Superior interpersonal and communication skill
8. Good training skill
9. Responsible, professional, detail oriented and with patience
10.Flexible and works well in team
公司介绍
博士伦公司
博士伦是一家专门致力于保护并改善全世界数以百万计人们的视力的公司，它关照人们从出生到生命的各个阶段。我们的愿景简单却有力：帮助您实现清晰视觉，睛彩人生。
博士伦是全世界范围内享有盛誉，倍受尊重的医药保健品牌之一，我们提供包括隐形眼镜，镜片护理产品，眼科药品，眼内镜片以及其他眼睛外科手术产品在内的***泛，最优良的眼睛保健产品系列。
我们最优先考虑的是所服务的人们的健康和福利。通过对顾客和病患的倾听，持续改进我们的创新能力，正直而卓越地执行，努力赢得合作伙伴和利益相关人的信任。
在过去的150年里，博士伦已经成为全球范围内创新和品质的代名词。我们富有天赋和动力的同事们不辞辛劳地研发新材料，创造新技术，最终利用新发明帮助人们实现清晰视觉，睛彩人生。
博士伦中国
博士伦在中国有三家独立运行的公司和两家工厂，分别是北京博士伦眼睛护理产品有限公司，博士伦（上海）贸易有限公司和山东博士伦福瑞达制药有限公司,工厂分别位于山东济南和北京。
北京博士伦眼睛护理产品有限公司，建立于1988。主要生产和销售代表世界先进水平的眼睛护理产品，包括透明镜片，彩色镜片，护理产品等，实现产品的全面覆盖。公司采用美国博士伦先进的产品技术和制造工艺，是行业***通过方圆及德国TUF公司ISO9002国际质量认证的眼睛护理产品制造和销售企业，和中国***通过ISO医疗器械质量体系认证的隐形眼镜制造和销售商。
博士伦（上海）贸易有限公司, 主要经营博士伦眼科手术产品。博士伦眼科手术产品是博士伦大家庭中最重要的成员之一，代表了博士伦立足于发展眼科高科技的企业形象。博士伦眼科手术产品主要包括白内障、玻璃体视网膜手术设备、人工晶体、相关耗材和手术器械等，种类齐全, 技术先进, 设计合理, 质量优良, 多年来在国际眼科界得到广泛应用，使全世界无数的眼疾患者重新恢复了光明。
山东博士伦福瑞达制药有限公司，由美国博士伦公司于2005年投资山东正大福瑞达制药有限公司成立。山东正大福瑞达制药有限公司成立于1991年，是由山东福瑞达医药集团公司、泰国正大制药集团和美国福瑞达国际有限公司共同投资组建的中外合资企业。致力于生物技术产品和生化药品的研究开发、生产和销售。
About Bausch + Lomb
Bausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.
Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.
Over the last 150 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.
Bausch + Lomb China
Bausch + Lomb China consists of three independent legal entities with two manufacturing plants in China. They are Beijing Bausch + Lomb Eyecare Co., Ltd, Bausch + Lomb (Shanghai) Trading Co., Ltd. and Shandong Bausch + Lomb Freda Pharmaceutical Co. Ltd. The two plants are separately located in Jinan and Beijing.
Beijing Bausch + Lomb Eyecare Co., Ltd, founded in 1988, mainly provides eye care products. We adopt advanced technology and process. Our eye care products represent the advanced level in the world. Our contact lens business offerings span the entire spectrum of wearing modalities and include contact lens, cosmetic lens, solutions and drops. We are the first eye care company that certified by TUF German standards and ISO9002, and that acquired ISO medical equipment quality system certificate in China.
Bausch + Lomb (Shanghai) Trading Co., Ltd., engaged in the business of a full suite of ophthalmic surgical products including cataract surgery equipment, intraocular lenses and delivery systems featuring IOLs, and other surgical instruments and devices. Our Surgical products offer a range of precision-engineered and quality equipments and instruments to serve the needs of all ophthalmic surgeons.
Shandong Bausch + Lomb Freda Pharmaceutical Co. Ltd., founded as a joint venture in 2005, committed to research and develop, manufacture and sale of ophthalmic drugs. The company formerly known as Shandong Chia Tai Freda Pharmaceutical Group was set up in 1991, invested by Shandong Freda, Chia Tai Pharmaceutical Group, American Freda International.
博士伦是一家专门致力于保护并改善全世界数以百万计人们的视力的公司，它关照人们从出生到生命的各个阶段。我们的愿景简单却有力：帮助您实现清晰视觉，睛彩人生。
博士伦是全世界范围内享有盛誉，倍受尊重的医药保健品牌之一，我们提供包括隐形眼镜，镜片护理产品，眼科药品，眼内镜片以及其他眼睛外科手术产品在内的***泛，最优良的眼睛保健产品系列。
我们最优先考虑的是所服务的人们的健康和福利。通过对顾客和病患的倾听，持续改进我们的创新能力，正直而卓越地执行，努力赢得合作伙伴和利益相关人的信任。
在过去的150年里，博士伦已经成为全球范围内创新和品质的代名词。我们富有天赋和动力的同事们不辞辛劳地研发新材料，创造新技术，最终利用新发明帮助人们实现清晰视觉，睛彩人生。
博士伦中国
博士伦在中国有三家独立运行的公司和两家工厂，分别是北京博士伦眼睛护理产品有限公司，博士伦（上海）贸易有限公司和山东博士伦福瑞达制药有限公司,工厂分别位于山东济南和北京。
北京博士伦眼睛护理产品有限公司，建立于1988。主要生产和销售代表世界先进水平的眼睛护理产品，包括透明镜片，彩色镜片，护理产品等，实现产品的全面覆盖。公司采用美国博士伦先进的产品技术和制造工艺，是行业***通过方圆及德国TUF公司ISO9002国际质量认证的眼睛护理产品制造和销售企业，和中国***通过ISO医疗器械质量体系认证的隐形眼镜制造和销售商。
博士伦（上海）贸易有限公司, 主要经营博士伦眼科手术产品。博士伦眼科手术产品是博士伦大家庭中最重要的成员之一，代表了博士伦立足于发展眼科高科技的企业形象。博士伦眼科手术产品主要包括白内障、玻璃体视网膜手术设备、人工晶体、相关耗材和手术器械等，种类齐全, 技术先进, 设计合理, 质量优良, 多年来在国际眼科界得到广泛应用，使全世界无数的眼疾患者重新恢复了光明。
山东博士伦福瑞达制药有限公司，由美国博士伦公司于2005年投资山东正大福瑞达制药有限公司成立。山东正大福瑞达制药有限公司成立于1991年，是由山东福瑞达医药集团公司、泰国正大制药集团和美国福瑞达国际有限公司共同投资组建的中外合资企业。致力于生物技术产品和生化药品的研究开发、生产和销售。
About Bausch + Lomb
Bausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.
Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.
Over the last 150 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.
Bausch + Lomb China
Bausch + Lomb China consists of three independent legal entities with two manufacturing plants in China. They are Beijing Bausch + Lomb Eyecare Co., Ltd, Bausch + Lomb (Shanghai) Trading Co., Ltd. and Shandong Bausch + Lomb Freda Pharmaceutical Co. Ltd. The two plants are separately located in Jinan and Beijing.
Beijing Bausch + Lomb Eyecare Co., Ltd, founded in 1988, mainly provides eye care products. We adopt advanced technology and process. Our eye care products represent the advanced level in the world. Our contact lens business offerings span the entire spectrum of wearing modalities and include contact lens, cosmetic lens, solutions and drops. We are the first eye care company that certified by TUF German standards and ISO9002, and that acquired ISO medical equipment quality system certificate in China.
Bausch + Lomb (Shanghai) Trading Co., Ltd., engaged in the business of a full suite of ophthalmic surgical products including cataract surgery equipment, intraocular lenses and delivery systems featuring IOLs, and other surgical instruments and devices. Our Surgical products offer a range of precision-engineered and quality equipments and instruments to serve the needs of all ophthalmic surgeons.
Shandong Bausch + Lomb Freda Pharmaceutical Co. Ltd., founded as a joint venture in 2005, committed to research and develop, manufacture and sale of ophthalmic drugs. The company formerly known as Shandong Chia Tai Freda Pharmaceutical Group was set up in 1991, invested by Shandong Freda, Chia Tai Pharmaceutical Group, American Freda International.
联系方式
- Email：staffing.china@bausch.com
- 电话：13816871328