Ergomed
Pharmacovigilance
AssociateClientQualityManager
Neural analysis suggests this role is
optimal for mid candidates.
“Associate Client Quality Manager at Ergomed. Skills: Quality Management, Client Management, Pharmacovigilance. Implement quality system. Maintain quality system”
What You'll Achieve.
high-quality client service
Industry & Context.
What They're Looking For.
Must Have
Life Sciences degree, pharmacovigilance experience, quality and compliance experience, GxP environment experience, case processing experience, Good organisational skills, attention to detail, excellent communications skills, Experience in Project Management, Client management experience, Good IT skills
Nice to Have
leadership qualities, Line Management experience, mentoring experience
What You'll Do.
Implement quality system
Maintain quality system
Provide training for client projects
Ensure project compliance
Oversight of project quality activities
Drive project quality improvement
Provide quality advice
Oversight for client quality activities
Develop Quality Management Plan
Maintain Quality Management Plan
Act as contact for audit activities
Involvement in Deviation Management
Involvement in CAPA Management
Ensure quality KPIs established
Provide quality content for reports
Provide analysis for reports
Work with Quality Management teams
Work with Quality Assurance teams
Work with Audit Management teams
Support junior team members
Line management responsibilities
Involvement in employee training
How You'll Work.
Team & Collaboration
Quality Management teams; Quality Assurance teams; Audit Management teams; colleagues based all over the world
Communication Scope
Client communication
Process & Methodology
Project Management
Full Job Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. 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. The Client Quality Manager (CQM) is primarily responsible for the implementation and maintenance of the quality system and training for their assigned client projects, ensuring that the project maintains compliance with global regulations, legislation, PrimeVigilance and Client requirements. Core responsibilities include: * Oversight of all project related quality activities * Drive project related quality improvement and providing quality advice * Client management including direct oversight for client quality related activities for project. * Develop and maintain a project specific Quality Management Plan. * May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities * Ensures relevant quality KPIs are established and monitored * Provide quality content and analysis for project monthly reports * Working closely with Quality Management, Quality
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