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 position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.  

Contributes to achieving company´s goals and objectives. 

Works independently. 

The position will maintain and manage PSMF for clients, activities will include PSMF:  

• Authoring 

• Revision 

• Quality check review 

• Tracking 

Attend regular PSMF meetings with internal employees and Clients.  

Fulfilment of tasks assigned by the Line Manager. 

May be assigned as a supervisor for less experienced colleagues. 

Provision of training in PSMF area. 

Revision and update of PSMF related quality documents. 

More senior colleague may perform tasks assigned as per SOP to more junior position. 

Life science graduate, pharmacy, nursing or other healthcare related qualification 

Demonstrated experience in Pharmacovigilance

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