Pharmaceutical Affairs Manager, Vietnam
Văn Phòng Đại Diện Aspen Pharmacare Australia Pty Limited Tại Thành Phố Hồ Chí Minh.
Địa điểm làm việc: Hà Nội
Hết hạn: 15/12/2023
- Chi tiết công việc
- Giới thiệu công ty
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Mô tả công việc
Position description
Liaise and manage the regulatory, pharmacovigilance ("PV") and medical governance ("MG") matters in Vietnam.
Accountabilities and Activities
• Compilation and submission of new product registrations, license renewals, variations, site registrations, life cycle management activities.
• Maintain good record, databases, filing system of product registration and licenses and reviewing new business development dossiers for Vietnam.
• Responsible for developing and enhancing relationships with key external agencies (regulatory agencies and if applicable, service providers). Manage the interface with government departments throughout the lifecycle of a product and develop a long-term and positive relationship characterized by Integrity and Compliance.
• Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner to achieve business objectives.
• Liaise with distributor to manage product quality complaint.
• Develop effective PV strategies, systems, and procedures to align with business strategies, organizational policies, and local regulations.
• Responsible for managing MG functions throughout product lifecycle to align with the organization's strategy, operations, regulatory, legal, and risk requirements.
• Provide recommendations and decisions on PV and MG issues including proactive risk management and mitigation.
• Responsible for new employee training and annual/periodic training of Enquiry Handling Training and related procedural training.
• Handle ad-hoc request/project requested by supervisor.
• Work in unison with Aspen's local, Asia regional, Global and Group functions to deliver the desired outcome
Position Objectives and/or Key Result Areas
• Ensure compliance with, and maintenance of, the existing licenses for Aspen's portfolio, effective and timely approval of all marketing authorizations
• Define Regulatory priorities in line with the business objectives
Liaise and manage the regulatory, pharmacovigilance ("PV") and medical governance ("MG") matters in Vietnam.
Accountabilities and Activities
• Compilation and submission of new product registrations, license renewals, variations, site registrations, life cycle management activities.
• Maintain good record, databases, filing system of product registration and licenses and reviewing new business development dossiers for Vietnam.
• Responsible for developing and enhancing relationships with key external agencies (regulatory agencies and if applicable, service providers). Manage the interface with government departments throughout the lifecycle of a product and develop a long-term and positive relationship characterized by Integrity and Compliance.
• Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner to achieve business objectives.
• Liaise with distributor to manage product quality complaint.
• Develop effective PV strategies, systems, and procedures to align with business strategies, organizational policies, and local regulations.
• Responsible for managing MG functions throughout product lifecycle to align with the organization's strategy, operations, regulatory, legal, and risk requirements.
• Provide recommendations and decisions on PV and MG issues including proactive risk management and mitigation.
• Responsible for new employee training and annual/periodic training of Enquiry Handling Training and related procedural training.
• Handle ad-hoc request/project requested by supervisor.
• Work in unison with Aspen's local, Asia regional, Global and Group functions to deliver the desired outcome
Position Objectives and/or Key Result Areas
• Ensure compliance with, and maintenance of, the existing licenses for Aspen's portfolio, effective and timely approval of all marketing authorizations
• Define Regulatory priorities in line with the business objectives
Yêu cầu
Skills & Knowledge
• Good team player
• Well-organized, communication and problem solving skills
• Proficiency in MS Word, Excel, PowerPoint
Experiences:
• 3 - 5 years or above regulatory affairs experience
• 2 - 3 years or above pharmacovigilance and medical governance experience
Certifications & Qualifications
• Bachelor's degree holder of related field
• Good command of written and spoken English and Vietnamese
• Good team player
• Well-organized, communication and problem solving skills
• Proficiency in MS Word, Excel, PowerPoint
Experiences:
• 3 - 5 years or above regulatory affairs experience
• 2 - 3 years or above pharmacovigilance and medical governance experience
Certifications & Qualifications
• Bachelor's degree holder of related field
• Good command of written and spoken English and Vietnamese
Quyền lợi
Medical Insurance for employee
Perfomance Bonus + 13th month salary
Training
Perfomance Bonus + 13th month salary
Training
Thông tin khác
Ngày Đăng Tuyển
15/11/2023
Cấp Bậc
Trưởng phòng
Ngành Nghề
Chính Phủ/Phi Lợi Nhuận > Chính sách, Quy hoạch & Quy định
Lĩnh vực
Dược phẩm
Kỹ Năng
Regulatory Affairs, Medical Affairs, License Management, Product Registration, Compliance
Ngôn Ngữ Trình Bày Hồ Sơ
Tiếng Anh
15/11/2023
Cấp Bậc
Trưởng phòng
Ngành Nghề
Chính Phủ/Phi Lợi Nhuận > Chính sách, Quy hoạch & Quy định
Lĩnh vực
Dược phẩm
Kỹ Năng
Regulatory Affairs, Medical Affairs, License Management, Product Registration, Compliance
Ngôn Ngữ Trình Bày Hồ Sơ
Tiếng Anh
Thông tin chung
- Ngày hết hạn: 15/12/2023
- Thu nhập: Thương lượng
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