Ph3Job Description /h3 ul liProviding support to other activities undertaken by the project team on behalf of the client and the company /li liPerforming activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to) : /li liProcessing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines /li liPerforming ICSR follow up /li liSAE / SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) /li liReconciliation (clinical, partners) /li liPersonal data protection /li liProduct Quality Complaint handling and interaction with Quality Assurance /li liMedical Information interaction /li liMedDRA and WHO coding /li liDatabase Outputs and Reports (including data for monthly reporting to clients) /li liWorkflow resource management /li liMentoring and training of new and more junior employees within the department /li liSupport of PV processes related to the ICSR management within PrimeVigilance and also to clients /li liSupporting ICSR SMEs and contributing as one of ICSR SMEs /li liPerforming activities in the scope of ICSR management unit within agreed extent and timeframe /li liSupporting 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 /ul h3Qualifications /h3 ul liLife science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance /li liExtensive ICSR experience including mentoring and leading reports /li liExcellent communication (written and verbal) skills /li liOrganization skills, including attention to details and multitasking /li liDelegation skills /li liPlanning and time management /li liTechnical skills /li liTeam working /li liEnglish – fluent (spoken, written) /li /ul h3Additional Information /h3 h3Why PrimeVigilance? /h3 pWe 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. /p pTo 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. /p h3We offer : /h3 ul liTraining and career development opportunities internally /li liStrong emphasis on personal and professional growth /li liFriendly, supportive working environment /li liOpportunity to work with colleagues based all over the world, with English as the company language /li /ul pOur 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! /p ul liQuality /li liIntegrity Trust /li liDrive Passion /li liAgility Responsiveness /liliBelonging /li liCollaborative Partnerships /li /ul pWe look forward to welcoming your application. /p /p #J-18808-Ljbffr