PrimeVigilance, an Ergomed brand, was established 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.

Provides support and advice to all PrimeVigilance functional teams to ensure that the company’s quality management system (QMS) is established and maintained to the highest quality and that it is compliant with global regulations, legislation and PrimeVigilance requirements.

• Supports and advises PrimeVigilance functional teams in identifying, reporting and addressing deviations and quality-related issues
• Supports and advises PrimeVigilance functional teams in creating, managing and implementing CAPA plans
• Identifies and escalates serious and/or systemic issues to Quality Leadership Team
• Supports the Quality department in the review and approval of PrimeVigilance Controlled Procedures
• Supports the Quality department in obtaining and trending metrics data for oversight of and reporting on PrimeVigilance’s Quality Management System

• Provide training and mentoring on relevant Quality activities

Qualifications

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

Demonstrated Pharmacovigilance experience is essential.

Prior experience in a Quality and/or Compliance role is highly desirable.

Prior experience in Medical Information, Medical Devices or IT is desirable but not required

Experience of using a safety database (e.g. ARISg, ARGUS) desirable but not required.

Experience of using an electronic Quality Management System desirable but not required.

Fluent in English

MS Office, particularly advanced skills in Excel and Word.

All your information will be kept confidential according to EEO guidelines.

Our Offer:

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