Operational Quality Officer

**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.

The Operational Quality Officer is responsible for ensuring departmental quality activities are completed on time, following detailed investigations to a high level of quality. The role will be responsible for departmental management of non-conformities, deviation, corrective and preventive actions and audit and inspection responses. In addition, this role will drive quality and compliance by ensuring completion of key quality tasks and ensuring they are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

**Role and Responsibilities**
- Responsible for the deviations and CAPAs in their department, working with SMEs
- Supports Subject Matter Experts to conduct root cause analysis or deviations and CAPAs
- Ensures timely completion of actions
- Acts as point of contact for delivery of audit and inspection CAPA preparation and delivery of actions within agreed timelines
- Drives audit and inspection readiness within their department
- Reviews data to drive continuous improvement and excellence in quality.
- Delivers proactive department specific audit and inspection readiness training,
- Works with department SMEs to arrange targeted interview practice
- Contributes to development of training material for departmental quality
- Ensures delivery of data required for quality and compliance metrics
- Works closely with quality counterparts and head of department to drive improvement of departmental quality

**Qualifications**
- University degree in Biomedical sciences, or relevant experience.
- Experience with Pharmacovigilance/MI experience is required
- Prior experience in a Quality and/or Compliance role is required
- Problem Solving skills, approaching issues independently, and using one’s own initiative is necessary

**Special Skills**

Experience of using an electronic Quality Management System desirable

**Language skills**

Fluent in verbal and written English
**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.

**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
- Extensive and specialized trainings in pharmacovigilance - internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year

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