Quality Management Officer, Document Management

5 days ago

Belgrade, Central Serbia Ergomed Full time
Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.  

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.  

We have nourished a true international culture here at Ergomed.  

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 Management Officer for the Document Management team is responsible for ensuring that PrimeVigilance's controlled procedures are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

ROLE AND RESPONSIBILITIES

  • Supporting the administration, tracking and management of PrimeVigilance Controlled Procedures
  • Managing and maintaining the PrimeVigilance electronic Quality Management System (eQMS)
  • Reviewing and approving Access Requests to PrimeVigilance's controlled systems
  • Supporting audits and inspections by providing reports and procedures from the PrimeVigilance eQMS
  • Providing controlled copies of PrimeVigilance procedures to clients as needed
  • Supporting PrimeVigilance functional teams in recording and tracking planned deviations and resulting CAPA plans against PrimeVigilance Controlled Procedures in eQMS as needed
  • Providing training and mentoring to new starts as needed
  • Assist the Senior Quality Manager with business related projects as needed
  • May act as a Trainer for QMS-related training activities provided by the Quality Management department
Qualifications

Educated to degree standard or appropriate equivalent work experience

  • Required: Relevant experience in a Quality and/or Compliance-related role
  • Desirable: Prior experience in Pharmacovigilance, Medical Information, or Medical Devices
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 Offer:

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth

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