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.  

Job Description

Role and Responsibilities

The Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Officer will perform all activities described, including but not limited to:

Audit Support:Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA functionHosts onsite and remote auditsProvides support for regulatory inspections of clientsAssists in scheduling client requests for audits/inspection supportAdministrative supportSupports Quality in the tracking of audit status and deliverablesMetrics and Key Performance IndicatorsSupports Quality in the compilation and reporting of metrics and KPIsCollects and collates data from systems and sourcesAuthors reports and summariesCAPA Support ActivitiesSupports Quality in the tracking of Deviations and CAPAsFacilitates CAPA response and resolutionInputs data into the global audit CAPA trackerOther Supportive Responsibilities: Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGsSupports the PrimeVigilance Senior Leadership team as needed.Supports other Quality activities as needed.

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with pharmaceutical industry experience. Or equivalent pharmaceutical industry experience.

Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare

Thorough understanding of the principles of Quality Assurance

Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information

Experience of participating in audits and inspections

Excellent communication and facilitation skills within a global organisation

Proactive and self-motivated

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 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  

We look forward to welcoming your application.