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.

A managerial position in the Quality Management department to ensure all Quality Operations activities are performed and managed appropriately ensure all PrimeVigilance functional teams receive the support and advice they require to comply with the company’s Quality Management System.

For the Company:

Lead the Quality Operations teams to ensure that the quality of PrimeVigilance’s activities are in compliance with applicable regulatory requirements, and that its clients’ Sponsor and Marketing Authorisation Holder obligations are fulfilled.

Quality Events, non-conformities, and CAPAs

• Ensures support and advice to PrimeVigilance functional teams is provided in identifying, reporting and addressing Quality Events, non-conformities and issues
• Review and approve the need for a CAPA plan
• Ensures support and advice to PrimeVigilance functional teams is provided in creating, managing and implementing CAPA plans
• Identify and escalate serious and/or systemic issues to (Associate) Director of Quality Management.
• Performs periodic trending of Quality Events data across the company

Quality Management Control System (QMCS)

• Supports the Quality Management department in developing, managing and implementing PrimeVigilance Controlled Procedures and related training
• Supports and advises the PrimeVigilance functional teams in developing and managing project-specific documentation and in managing relevant project-specific training

Audits and inspections

• Ensures support to PrimeVigilance functional teams pre-, during and post-audits by clients or by internal QA function
• Ensures support to PrimeVigilance functional teams pre-, during and post-inspections of PrimeVigilance’s clients
• Participates, as required, in audits and inspections as a Subject Matter Expert for the Quality Management function

For the Client:

• Support the development and documentation of non-conformities, Quality Events and CAPAs for each client project in a centralised tracking system.
• Provide clients with PV Quality and Compliance consultancy, as required
• Support improvement opportunities for client-specific activities

• Educated to degree standard.
• Extensive experience working within Pharmacovigilance.
• Significant experience in a Quality and Compliance role.
• First class analytical and investigative skills
• Previous line management experience is desirable

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