Pharmacovigilance Manager
Mức lương: Thỏa thuận
Đã hết hạn nộp hồ sơ - 766 lượt xem
Ngày cập nhật: 17/03/2020
Thông Tin Tuyển Dụng
Mô tả công việc
• Responsible for pharmacovigilance and counterfeit activities (receive AE information, record, send report to Clients)
• Responsible for training relevant section about SOP- Adverse Event report
• Responsible for reviewing PV agreement between DKSH and Clients
• Responsible for joining with company quality circle to maintain quality system
• Responsible for advertising/ symposium dossiers
• Supports RA management to make the report to management/ report to Health authority
• To perform Individual Case Safety Report (ICSR) quality control (QC)
• To close processed ICSRs
• To report spontaneous ICSRS to Health Authority - create hard copy template for the PV Associate to adapt and distribute
• To report Suspected Unexpected Serious Adverse Reactions to Health Authorities, ECs and investigators - create hard copy template for the PV Associate to adapt and distribute
• To perform electronic reporting to Health Authority via EV Web Trader, including testing of the system and registration with Eudravigilance and the local authorities for this purpose
• To perform ICSR reconciliation with business partners, if required
• To track ICSRs
• To translate documents into English, if applicable
• To write or contribute to PSURs and ASRs as required. This may include acting as the project coordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.
• To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required.
• To review literature screening search results, identifying ICSRs and other safety-related findings.
• Responsible for training relevant section about SOP- Adverse Event report
• Responsible for reviewing PV agreement between DKSH and Clients
• Responsible for joining with company quality circle to maintain quality system
• Responsible for advertising/ symposium dossiers
• Supports RA management to make the report to management/ report to Health authority
• To perform Individual Case Safety Report (ICSR) quality control (QC)
• To close processed ICSRs
• To report spontaneous ICSRS to Health Authority - create hard copy template for the PV Associate to adapt and distribute
• To report Suspected Unexpected Serious Adverse Reactions to Health Authorities, ECs and investigators - create hard copy template for the PV Associate to adapt and distribute
• To perform electronic reporting to Health Authority via EV Web Trader, including testing of the system and registration with Eudravigilance and the local authorities for this purpose
• To perform ICSR reconciliation with business partners, if required
• To track ICSRs
• To translate documents into English, if applicable
• To write or contribute to PSURs and ASRs as required. This may include acting as the project coordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.
• To assist with pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required.
• To review literature screening search results, identifying ICSRs and other safety-related findings.
Yêu cầu ứng viên
• Good leadership & interpersonal skills, coaching & developing people
• Problem solving & decision making, analytical skills
• Fluent in English
• Good command in office computer skills
• At least 3 years experience in relevant field
• Problem solving & decision making, analytical skills
• Fluent in English
• Good command in office computer skills
• At least 3 years experience in relevant field
Quyền lợi được hưởng
- Performance bonus
- Healthcare program
- Training plan
- Healthcare program
- Training plan
Cách thức ứng tuyển
Hồ sơ theo yêu cầu của nhà tuyển dụng khi liên hệ trực tiếp
Giới thiệu về công ty

DKSH VIETNAM CO., LTD.
5th Floor, Viettel Complex Tower, 285 Cach Mang Thang Tam Street, Ward 12, District 10, Ho Chi Minh City, Vietnam
Người liên hệ: HR Dept
5th Floor, Viettel Complex Tower, 285 Cach Mang Thang Tam Street, Ward 12, District 10, Ho Chi Minh City, Vietnam
Người liên hệ: HR Dept
DKSH is the leading Market Expansion Services provider with a focus on Asia. As the term "Market Expansion Services" suggests, DKSH helps other companies and brands to grow their business in new or existing markets. Publicly listed on the SIX Swiss Exchange since March 2012, DKSH is a global company ...Chi tiết
DKSH is the leading Market Expansion Services provider with a focus on Asia. As the term "Market Expansion Services" suggests, DKSH helps other companies and brands to grow their business in new or existing markets. Publicly listed on the SIX Swiss Exchange since March 2012, DKSH is a global company headquartered in Zurich. With 750 business locations in 35 countries – 720 of them in Asia – and 27,600 specialized staff, DKSH generated net sales of CHF 9.8 billion in 2014. The company offers a tailor-made, integrated portfolio of sourcing, marketing, sales, distribution, and after-sales services. It provides business partners with expertise as well as on-the-ground logistics based on a comprehensive network of unique size and depth. Business activities are organized into four specialized Business Units that mirror DKSH fields of expertise: Consumer Goods, Healthcare, Performance Materials, and Technology. In 2015, DKSH celebrates its 150th anniversary. With strong Swiss heritage, the company has a long tradition of doing business in and with Asia, and is deeply rooted in communities and businesses across Asia Pacific. With us you can: • Work in an international environment of employees, customers and suppliers • Develop your entrepreneurial mindset with a global and successful company • Grow businesses, expand your professional expertise, excel in your career • Take ownership of what you do, be accountable for outcomes, receive recognition for achievements • Expand your horizon as part of a truly multicultural and diverse team • Impact the daily lives of millions of people around the globe • Work with like-minded people toward one vision • Be a leader as part of a high performance team in a challenging environment Ẩn chi tiết
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Tìm thêm việc làm
DKSH VIETNAM CO., LTD.
Địa chỉ: 5th Floor, Viettel Complex Tower, 285 Cach Mang Thang Tam Street, Ward 12, District 10, Ho Chi Minh City, Vietnam
Quy mô: 1.000-4.999 nhân viên