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.
Job Description:Position Summary - Summary of Key Responsibilities
The Senior Quality Assurance Manager ensures continuous quality improvement through effective management and oversight of Audits and Inspections. Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training. The Senior Quality Assurance Manager leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts. The Senior Quality Assurance Manager ensure that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
Roles and Responsibilities
Specified Additional Responsibilities
Qualifications:
Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-related Quality Management and Assurance
Sound knowledge of international regulations related to Pharmacovigilance and Medical Information
Experience of participating in audits and inspections
Ability to lead, mentor, and develop teams
Excellent communication and facilitation skills within a global organization
Proactive and self-motivated with strong organizational and planning abilities
Excellent problem-solving and decision-making skills
Attention to detail and commitment to high standards
Ability to analyze data and prepare detailed reports
Knowledge of quality management principles and practices
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:
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!
We look forward to welcoming your application.