Client Quality Assistant

Posted 7 Hours Ago
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Pune, Mahārāshtra
Junior
Biotech • Pharmaceutical
The Role
The Client Quality Assistant supports administrative tasks for the Client Quality team, ensuring compliance with quality regulations and managing document preparations and project planning.
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

POSITION SUMMARY

The Client Quality Assistant supports the Client Quality team with administrative tasks, including but not limited to tracking, document preparation, compliance assessment and project planning. The Client Quality Assistant supports the Client Quality team in ensuring that its activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Drives quality and compliance by ensuring tracking of completion of key quality tasks for projects.

Role and Responsibilities

Key responsibilities include (but are not limited to):

  • Document organisation
  • Data retrieval and tracking for different purposes
  • Conduct periodic training reconciliation and maintenance of training matrix
  • Generate metrics and KPI assessment
  • Prepare documents´ drafts and/or final lay out, as applicable
  • Organise meetings and teleconferences
  • Assist with the organisation of Client Quality department
  • Perform other miscellaneous administrative tasks, as applicable
  • 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

  • University graduate
  • Advanced English (both spoken and written)
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
  • 2-3 yrs of experience in an administrative position involving management and creation of reports
  • Strong communication skills, attention to detail and problem-solving abilities

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 Ergomed is a great company to join!  

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

We look forward to welcoming your application!

Top Skills

Excel
Microsoft Word
PowerPoint
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The Company
HQ: Raleigh, NC
535 Employees
On-site Workplace
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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