PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

The Quality Officer, Quality Projects and Metrics, supports the Quality Projects and Metrics Team in ensuring that PrimeVigilance’s Quality and Compliance Metrics are compiled, analyzed and reported in compliance with global regulations, legislation and PrimeVigilance requirements.

Activities include, but are not limited to:

• Ensuring that metrics are gathered from relevant departments
• Compilation of reports and identification of missed KPIs and potential trends
• Performing an initial review of metrics and drafting the quality comments
• Identifying improvement opportunities based on trends and non-compliance
• Ensuring circulation of reports, at review step and finalization step, to the appropriate distribution lists within agreed timelines
• Following up with relevant employees to obtain missing data and responses
• Escalation of any potential issues to (Associate) Manager, Quality Projects and Metrics
• Tracking of all actions through to completion
• Update and maintenance of procedural documents and templates relating to the Q&C process in the PrimeVigilance Quality Management Control System
• Provision of Quality and Compliance Metrics Data when requested for the purposes of audits and inspections
• Providing support in iidentifying the key areas required for monitoring Quality and Compliance throughout the operational teams and agreeing suitable KPIs with functional heads in order to generate meaningful and useful quality and compliance data.
• Maintaining oversight of the compilation, analysis and reporting of Quality and Compliance Metrics and ensuring that deliverables are provided on time.

• Educated to degree standard or appropriate equivalent work experience.
• Previous experience working in a Quality and/or Compliance role.
• Previous Pharmacovigilance experience.
• Previous experience within a service provider environment.
• Excellent skills in planning, organisation and communication.

• Work within a successful, highly – qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company