Ph3Company Description /h3pWe 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. /ppPrimeVigilance 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. /ppWe 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. /ppCome and join us in this exciting journey to make a positive impact in patient’s lives. /ph3Job Description /h3ulliProviding support to other activities undertaken by the project team on behalf of the client and the company /liliPerforming activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): /liliProcessing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines /liliPerforming ICSR follow up /liliSAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) /liliReconciliation (clinical, partners) /liliPersonal data protection /liliProduct Quality Complaint handling and interaction with Quality Assurance /liliMedical Information interaction /liliMedDRA and WHO coding /liliDatabase Outputs and Reports (including data for monthly reporting to clients) /liliWorkflow resource management /liliMentoring and training of new and more junior employees within the department /liliSupport of PV processes related to the ICSR management within PrimeVigilance and also to clients /liliSupporting ICSR SMEs and contributing as one of ICSR SMEs /liliPerforming activities in the scope of ICSR management unit within agreed extent and timeframe /liliSupporting the RA PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager /li /ulh3Qualifications /h3ulliLife science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance /liliExtensive ICSR experience including mentoring and leading reports /liliExcellent communication (written and verbal) skills /liliOrganization skills, including attention to details and multitasking /liliDelegation skills · /liliPlanning and time management · /liliTechnical skills /liliTeam working /liliEnglish – fluent (spoken, written) /li /ulh3Additional Information /h3pWhy PrimeVigilance? /ppWe 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. /ppTo 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. /ppWe offer: /pulliTraining 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