Local Qualified Person for Pharmacovigilance

1 week 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

    7 months 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 -...


  • Hanoi, Vietnam Công ty Cổ phần Golden Path Academics Việt Nam Full time

    **Mô tả công việc**: (Mức lương: 10 - 18 triệu VNĐ) As a Personal Development Coach, you’ll work with each student on an individual basis to formulate customized strategies. General duties of a Personal Development Coach are consisted of, but not limited to the following (based on a 44-hour work week): - Working 1 on 1 with our students...


  • 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...


  • Hanoi, Vietnam British University Vietnam Full time

    **Job Description**: British University Vietnam (BUV) is the first and only international university in Vietnam to directly award British degrees from the prestigious University of London and Staffordshire University. BUV is rated a 5 Star university of excellence by the world recognised QS accreditor. BUV has three main brand drivers: - Offering...


  • Hanoi, Vietnam BI Vietnam Ltd Full time

    **The Position** - 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 / qualitative field...


  • 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...

  • Local C&b Officer

    2 weeks ago


    Hanoi, Vietnam Apollo Junior Full time

    **Job Description**: **1. C&B** - Ensure new and renewal labour contracts are prepared in a timely manner and well communicated to employees. - Be responsible for the accuracy of monthly payroll and SIMI calculation and declaration for employees - Prepare and submit monthly / quarterly PIT declaration & PIT finalization, dependant registration, tax code...


  • Hanoi, Vietnam MSD Full time

    **Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...


  • 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. -...


  • Hanoi, Vietnam MOVENPICK Full time

    **Company Description** Address: 83A Ly Thuong Kiet Str., Tran Hung Dao, Hoan Kiem, Hanoi Savour the good life at Mövenpick Hotel Hanoi Centre, a five-star hotel located in the central district of Hanoi. Boasting a residential feel in its services and design, the Hotel is primed to welcome business as well as leisure travelers to explore the charm of the...


  • Hanoi, Vietnam Boehringer Ingelheim Full time

    **Medical Representative in Quang Ninh** **-** **2212103** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse,...


  • 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,...

  • Revenue Manager

    5 days ago


    Hanoi, Vietnam Hyatt Regency West Hanoi Full time

    Summary **Purpose**: To provide the Hotel’s Marketing and Sales employees with internal and external marketing intelligence to support informed decisions resulting in an increase in the Hotel’s overall revenues and maximize profitability. **Key Responsibility**: - Analyses the current revenue generation trends of the Hotel in order to identify...


  • 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,...

  • Logistics Executive

    2 weeks ago


    Hanoi, Vietnam tesa Full time

    Location: - **Vietnam, Haiphong, Vietnam** - Level: - **Professionals** - Function: - **Procurement & Logistics** , - **Supply Chain** - About the role**This job is to ensure compliance to regulatory requirements and ensuring all Imp/Exp transactions are executed in a timely fashion** - What you will do- Main contact to local customs. - Ensure all import...


  • 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,...

  • Sales Executive

    7 months 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....


  • Hanoi, Vietnam BI Vietnam Ltd Full time

    **The Position **The District Promotion Manager is responsible for**: 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...


  • 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...


  • Hanoi, Vietnam Abbott Laboratories Full time

    **1, Summary**: Quality System implementation at the local EPD Commercial site and assures that quality related matters associated with products commercially distributed including those from Local TPM conform to current Good Manufacturing Practices (cGMP), Abbott Quality standards, and other applicable regulatory standards. **2, Core job...