Overview
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We cover services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance, with staff based across Europe, North America and Asia.
PrimeVigilance provides first class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and covering all therapy areas including medical device. We invest in our staff with training and development, value employee experience, well-being and work-life balance, and aim to deliver high-quality client service. This role is part of an exciting journey to make a positive impact in patient lives.
Role and Responsibilities
* Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
* Participate in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI when needed.
* Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
* Identifies and implements process improvements and efficiencies via IT solutions.
* Works with the Quality Assurance Manager to develop and train the hosting team in all activities associated with hosting.
* Works with the Quality Assurance Manager to continually develop and maintain training material for audit & Inspection attendees.
* Monitors and communicates trends seen in audits and Inspections to the Director of Quality Assurance.
* Works with the hosting team to develop and maintains an Inspection knowledge library.
* Proactively prepares the company and clients for regulatory inspections and audits.
* Collaborates and guides operational personnel to ensure effective audit and Inspection attendance.
* Generates metrics on audits and Inspections for Global Quality Council, Quality Leadership, Senior Leadership, and Management review purposes.
* Manages the electronic quality management system (EG-QMS) Audits module, identifying process improvements and initiating changes with the relevant IT SME to EG-QMS.
* Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.
* Acts as a Subject Matter Expert and client point-of-contact for Quality, including attendance at operational and quality governance meetings.
* Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with applicable laws and regulations including EU GVP, US FDA CFRs, JMPA and ICH-E6.
* Manages the audit and inspection hosting team.
* Conducts other ad hoc activities as requested by the Director of Quality Assurance and/or VP of Quality.
Qualifications
* A university degree in a healthcare discipline or equivalent scientific area
* Substantial experience in pharmaceutical/biotechnology pharmacovigilance with an in depth understanding of GVP/GCP-related Quality Management and Assurance
* Sound knowledge of international regulations related to Pharmacovigilance and Medical Information
* Significant experience of participating in audits and inspections
* Excellent communication and facilitation skills within a global organization
* Proactive and self-motivated
Special Skills
* Strong organizational and planning abilities
* Excellent problem-solving and decision-making skills
* Ability to lead, mentor, and develop teams
* Strong communication and interpersonal skills
* Attention to detail and commitment to high standards
* Ability to analyze data and prepare detailed reports
* Knowledge of quality management principles and practices
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. Our people are our greatest strength in improving the lives of those around us.
Benefits and Opportunities
* 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
Core Values
* Quality
* Integrity & Trust
* Drive & Passion
* Agility & Responsiveness
* Belonging
* Collaborative Partnerships
We look forward to welcoming your application.
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