Local Qualified Person for Pharmacovigilance

5 days ago

Hanoi, Vietnam IQVIA Full time

IQVIA Vietnam is looking to hire a **Local Qualified Person for Pharmacovigilance**. You will act as the **Qualified Person for PV (QPPV)** for customers requiring the services for their product. You will develop and prepare pharmacovigilance agreements for assigned customers, prepare pharmacovigilance systems master files under direct supervision.

**Responsibilities**:

- Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
- Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
- Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal l products.
- Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
- Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
- Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
- Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
- Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
- Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.

**Requirements**:

- Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
- Around 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
- ** Resident in Vietnam with fluent local language skills** & excellent command of the English language
- In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
- Excellent knowledge of the pharmacovigilance legal framework in the EU and in Vietnam.
- Solid knowledge of relevant Standard Operating Procedures (SOPs).
- Possess excellent written and verbal communication skills.
- Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.
- Strong organizational and project management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties
- Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
- Demonstrate an understanding of compliance and of quality management systems
- ** Availability by phone 24/7** for Competent Authority enquiries
- May require some travel

  • Personal Assistant

    1 week ago

    Hanoi, Vietnam CHI NHÁNH HÀ NỘI - CÔNG TY CỔ PHẦN SẢN XUẤT VÀ KINH DOANH VINFAST Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) - Manage the Director's schedule, appointments, and travel arrangements - Prepare and organize documents, weekly/monthly reports, and presentations - Prepare meeting agendas, take meeting minutes, and distribute notes and action items - Handle confidential information with the utmost discretion -...

  • Personal Assistant

    6 days ago

    Hanoi, Ha Noi, , Vietnam VinFast Full time $41,000 - $83,000 per year

    VINFAST is a pioneering electric vehicle (EV) company committed to revolutionizing the automotive industry with sustainable and innovative mobility solutions. As a leading player in the EV market, VinFast is dedicated to delivering high -quality, cutting -edge electric vehicles that redefine the driving experience. Our team consists of passionate...

  • Senior Medical Representative

    7 days ago

    Hanoi, Vietnam Merck KGaA Darmstadt Germany Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Medical Representative in Ha Noi

    7 days ago

    Hanoi, Vietnam BI Vietnam Ltd Full time

    **The **Position **Medical Representative - Orchestrating for Exceptional Customer Experience - focused on implementing in-clinic and virtual execution of the Customer Engagement Model. Implement Multi Channel Cycle Plans to target Customers, meet/exceed promotion targets for assigned product(s) within the allocated territory and achieve related quantitative...

  • Director of Human Resources

    5 days ago

    Hanoi, Vietnam Hyatt Regency West Hanoi Full time

    Summary **Administration** - Ensures that the Department’s activities are aligned with the Corporate Human Resources Strategy, and that the Hotel Actions have been implemented where appropriate. - Represents the Human Resources function on the hotel's Executive Committee. - Co-ordinates and monitors the activities of the Human Resources Division. -...

  • Information and Communication Technology Assistant

    1 week ago

    Hanoi, Hanoi, Vietnam International Organization for Migration Full time $25,000 - $40,000 per year

    Description Applications are welcome from internal and external candidates. For all IOM vacancies, applications from qualified and eligible first-tier candidates are considered before those of qualified and eligible second-tier candidates in the selection process. For the purpose of this vacancy, internal candidates are considered first-tier...

  • Information and Communication Technology Assistant

    1 week ago

    Hanoi, Hanoi, Vietnam INTERNATIONAL ORGANIZATION FOR MIGRATION Full time ₫4,500,000 - ₫6,000,000 per year

    Applications are welcome from internal and external candidates. For all IOM vacancies, applications from qualified and eligible first-tier candidates are considered before those of qualified and eligible second-tier candidates in the selection process. For the purpose of this vacancy, internal candidates are considered first-tier...

  • Sales Executive

    1 week ago

    Hanoi, Vietnam Khách sạn JW Marriott Hà Nội Full time

    **Mô tả công việc**: (Mức lương: Thỏa thuận) - Building Successful Relationships that Generate Sales Opportunities - Works collaboratively with off-property sales channels to ensure sales efforts are coordinated, complementary and not duplicative. - Builds and strengthens relationships with existing and new customers to enable future bookings....

  • District Promotion Manager in Ha Noi

    7 days ago

    Hanoi, Vietnam BI Vietnam Ltd Full time

    Managing Team/People - Directly supervises, builds and leads a team of Medical Representatives within responsible district through leading, coaching and managing talents. Managing Business / Performance: - Develops a District Plan to maximize the resource utilization and ensures execution, ensures targeting of most valuable customers, Field Force/CRM/New...

  • Senior Sales Manager

    1 day ago

    Hanoi, Vietnam Jobs for Humanity Full time

    Company Description Jobs for Humanity is dedicated to building an inclusive and just employment ecosystem. Therefore, we have dedicated this job posting to individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf of Hard of Hearing Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ,...