Client Quality Officer (PV) - Homebased in Europe at Ergomed in Dublin, County Dublin REF3126O

Client Quality Officer (PV) - Homebased in Europe

Pay Competitive

Location Dublin/County Dublin

Employment type Full-Time

Job Description

We are PrimeVigilance (part of Ergomed PLC), 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.

The Client Quality Officer 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

• Direct oversight for client quality related activities for project. Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project.
• Working closely with the Project Manager and Project Teams to ensure seamless delivery of all aspects of the Quality Cycle.
• Managing a variety of clients and expected to deliver work with limited input.
• Ensure the timely and complete training of employees within client projects.
• Creating and maintaining a project specific quality management plan for each of their assigned projects.
• The Client Quality Officer will oversee all activities described with the plan, including but not limited to: Regulatory Intelligence, SOPs and Joint Operating Guideline, Training, HR, Systems and Facilities, Quality and Compliance monitoring, audit related activities and Deviation and CAPA Management.

Minimum Requirements

• Life Sciences degree
• Previous pharmacovigilance experience including quality and compliance experience within a GxP environment
• Good organisational skills, attention to detail and excellent communications skills
• Must have leadership qualities (Line Management experience is desirable)
• Good IT skills

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

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.

About the Company

As a mid-size clinical development organisation, we assist our clients by providing a full-service solution tailored to their unique requirements.