We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient's lives.
The QA Associate will support the QA team to ensure internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures.
The QA Associate will conduct all activities described, including but not limited to:
Hosts/supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Quality Audit Manager and/or Director, Quality.
Supports PrimeVigilance functional teams pre-, during and post-audit by clients or by internal QA function
Assists in client specific requests for audit scheduling
Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint
Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.
CAPA Support Activities
Supports in tracking of the vendor audit CAPAs.
Support in the facilitation and review of vendor CAPA responses
Input into the global audit CAPA tracker
Ensures documents and trackers from internal system and/or vendor audits initiated by Primevigilance, are kept up to date.
Assists in the development and maintenance of the internal risk assessments.
Conducts other ad-hoc activities as requested by Quality Audits Manager and/or Director, Quality.
Qualifications
University degree in a scientific discipline, or equivalent industry experience
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!