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 will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality teams 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 function
• Hosts onsite and remote audits
• Provides support for regulatory inspections of clients
• Assists in scheduling client requests for audits/inspection support

Administrative support

• Supports Quality in the tracking of audit status and deliverables

Metrics and Key Performance Indicators

• Supports Quality in the compilation and reporting of metrics and KPIs
• Collects and collates data from systems and sources
• Authors reports and summaries

CAPA Support Activities

• Supports Quality in the tracking of Deviations and CAPAs
• Facilitates CAPA response and resolution
• Inputs data into the global audit CAPA tracker

 Other Supportive Responsibilities: 

• Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
• Supports the PrimeVigilance Senior Leadership team as needed.
• Supports other Quality activities as needed.
• Mentoring and training of new and more junior employees as required.

• University degree in Biomedical sciences, Natural sciences or Health Sciences

• 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 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 

• Familiarity with international regulations is desirable 

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