Client Quality Assistant

Posted 4 Days Ago
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2 Locations
In-Office or Remote
Entry level
Biotech • Pharmaceutical
The Role
The Client Quality Assistant supports administrative tasks in Client Quality Management, including data tracking, document preparation, training management, and report compilation.
Summary Generated by Built In
Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Job Description

 

The Client Quality Assistant supports the Client Quality Management team with administrative tasks, including but not limited to tracking, data and document preparation/review and access/training management.

Role and Responsibilities

The Client Quality Assistant will be responsible for all administrative activities associated with the maintenance and management of data for reports, documentation, and systems relevant to the Client Quality Management Department.

Key responsibilities include (but are not limited to):

  • Accurately creating and updating training courses and training assignments in the Learning Management System in a timely manner
  • Preparation of training reports, training completion monitoring and support with periodic training assignment reviews
  • Reviewing and approving Access Requests to PrimeVigilance’s controlled systems
  • Periodic CV/JD review
  • Assistance with preparation and compilation of data for regular reports
  • Following up with relevant employees/departments to obtain missing data and responses
  • Assistance with Quality Event/CAPA timelines monitoring and tracking all actions through to completion
  • Preparation of PrimeVigilance procedures and procedure lists for provision to clients
  • Assistance with preparation of documents for audit/inspection requests

Specified Additional Responsibilities

Other administrative support as required.

The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities.

    Qualifications

    • High school or university graduate
    • Advanced English (both spoken and written)
    • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
    • Experience in an administrative position involving management and creation of reports
    • Desirable experience in data gathering
    • Strong communication skills, attention to detail and problem-solving abilities
    • Ability to work well in a team

    Additional Information

    We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

    To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

    We offer: 

    • Training and career development opportunities internally
    • Strong emphasis on personal and professional growth 
    • Friendly, supportive working environment 
    • Opportunity to work with colleagues based all over the world, with English as the company language 

    Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

    • Quality 
    • Integrity & Trust  
    • Drive & Passion  
    • Agility & Responsiveness  
    • Belonging 
    • Collaborative Partnerships  

    Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.

    Top Skills

    Excel
    Ms-Office (Word
    Powerpoint)
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    The Company
    HQ: Raleigh, NC
    535 Employees
    Year Founded: 1997

    What We Do

    Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.

    • 1,400+ highly qualified professionals
    • Global full-service CRO
    • 25+ years of experience
    • Therapeutic specialization in oncology
    • Strong expertise in rare disease trials
    • Robust clinical safety system
    • Choice of leading drug safety databases

    Our key services include:
    • Clinical Research Services
    • Pharmacovigilance
    • Medical Information
    • Regulatory
    • Medical Writing
    • Site Management
    • Study Physician Support
    • Biostatistics
    • Patient Study Support

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