Ph3Overview /h3pWe 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. 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 staff with training and development, value employee experience, well-being and work-life balance to support high-quality client service. Come and join us in this exciting journey to make a positive impact in patient’s lives. /ph3Role And Responsibilities /h3ulliWorks with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting. /liliParticipate 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. /liliDrives ongoing quality improvement measures through communication of audit results and compliance guidance/training. /liliIdentifies and implements process improvements and efficiencies via IT solutions. /liliWorks with the Quality Assurance Manager to develop and train the hosting team in all activities associated with hosting. /liliWorks with the Quality Assurance Manager to continually develop and maintain training material for audit Inspection attendees. /liliMonitors and communicates trends seen in audits and Inspections to the Director of Quality Assurance. /liliWorks with the hosting team to develop and maintains an Inspection knowledge library. /liliProactively prepares the company and clients for regulatory inspections and audits. /liliCollaborates and guides operational personnel to ensure effective audit and Inspection attendance. /liliGenerates metrics on audits and Inspections for Global Quality Council, Quality Leadership, Senior Leadership, and Management review purposes. /liliManages the electronic quality management system (EG-QMS) Audits module. Identifying process improvements and initiating these changes with the relevant IT SME to EG-QMS. /liliFosters a culture of quality within the organisation as led by members of the Quality Leadership Team. /liliActs as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings. /liliAssists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6. /liliManages the audit and inspection hosting team. /liliConducts other ad hoc activities as requested by Director of Quality Assurance and/or VP of Quality. /li /ulh3Qualifications /h3ulliA university degree in a healthcare discipline or equivalent scientific area /liliSubstantial experience in pharmaceutical/biotechnology pharmacovigilance with an in depth understanding of GVP/GCP-related Quality Management and Assurance /liliSound knowledge of international regulations related to Pharmacovigilance and Medical Information /liliSignificant experience of participating in audits and inspections /liliExcellent communication and facilitation skills within a global organization /liliProactive and self-motivated /li /ulh3Special Skills /h3ulliStrong organizational and planning abilities /liliExcellent problem-solving and decision-making skills /liliAbility to lead, mentor, and develop teams /liliStrong communication and interpersonal skills /liliAttention to detail and commitment to high standards /liliAbility to analyze data and prepare detailed reports /liliKnowledge of quality management principles and practices /li /ulh3Additional Information /h3pWe 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. /ph3We Offer /h3ulliTraining and career development opportunities internally /liliStrong emphasis on personal and professional growth /liliFriendly, supportive working environment /liliOpportunity to work with colleagues based all over the world, with English as the company language /li /ulpOur 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! /pulliQuality /liliIntegrity Trust /liliDrive Passion /liliAgility Responsiveness /liliBelonging /liliCollaborative Partnerships /li /ulpWe look forward to welcoming your application. /p /p #J-18808-Ljbffr