Quality Assurance Coordinator

Posted 7 Days Ago
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Belgrade, Belgrade City, Central Serbia
In-Office
Entry level
Biotech • Pharmaceutical
The Role
The Quality Assurance Coordinator supports QA activities by managing administrative tasks, scheduling audits, maintaining document libraries, and assisting with onboarding.
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. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

The Quality Assurance Coordinator works with the PrimeVigilance Quality Assurance group  to support the group with quality activities related to administrative tasks, including compiling, tracking and retrieval of information, planning, department organisation and archiving. 

Role and Responsibilities

  • The Quality Assurance Coordinator will support Quality Assurance activities within PrimeVigilance.
  • The Quality Assurance Coordinator will co-ordinate the scheduling of audits and inspections with the relevant Subject Matter Expert (SME).
  • The Quality Assurance Coordinator will maintain the audit ready document libraries and ensure they are periodically reviewed.
    • Administrative support
      • Data entry and review of the status of data on the PrimeVigilance electronic quality management system (EG-QMS)
      • Preparing document drafts and/ or final layout/ formatting
      • Assisting with employee on-boarding tasks and intro sessions
    • Other Supportive Responsibilities:
      • The Quality Assurance Coordinator will support the PrimeVigilance Senior Leadership team as needed.
      • Other QA support as needed.

Qualifications

  • Educated to degree standard or appropriate equivalent work experience
  • Excellent communication (written and verbal) skills
  • Organization skills, including attention to detail and multitasking
  • Planning and time management
  • Team working 

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  

We look forward to welcoming your application. 

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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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