Ergomed

Pharmacovigilance

AssociateClientQualityManager

€75–110k ~AI est. Bucharest, Bucharest, Romania FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Associate Client Quality Manager at Ergomed. Skills: Client quality, Quality system, Pharmacovigilance. Oversee project related quality activities. Drive project related quality improvement”

What You'll Achieve.

Maintain compliance with regulations; Achieve client requirements; Achieve PrimeVigilance requirements

Industry & Context.

Pharmacovigilance

What They're Looking For.

Must Have

Life Sciences degree, Previous pharmacovigilance experience, Quality and compliance experience, GxP environment experience, Case processing experience, Project Management experience, Client management experience, Good IT skills

Nice to Have

Line Management experience, Mentoring experience

What You'll Do.

Oversee project related quality activities

Drive project related quality improvement

Provide quality advice

Manage client quality related activities

Develop Quality Management Plan

Maintain Quality Management Plan

Act as main point of contact for audit

Involve in Deviation Management

Involve in CAPA Management

Ensure quality KPIs are established

Provide quality content for reports

Provide analysis for reports

Adhere to company QMS

Support junior team members

Perform line management responsibilities

Train employees on client projects

How You'll Work.

Team & Collaboration

Quality Management teams; Quality Assurance teams; Audit Management teams

Communication Scope

Communications skills

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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