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Company DescriptionWe are PrimeVigilance (part of Ergomed PLC), 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 DescriptionPerforming activities in the scope of ICSR management unit within agreed extent and timeframe:Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelinesPerforming ICSR follow upSAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)Reconciliation (clinical, partners)Personal data protectionProduct Quality Complaint handling and interaction with Quality AssuranceMedical Information interactionMedDRA and WHO codingDatabase Outputs and Reports (including data for monthly reporting to clients)Workflow & resource managementSupport of PV processes related to the ICSR management within PrimeVigilance and also to clientsMore senior colleague may perform tasks assigned as per SOP to more junior positionPerforming activities in the scope of ICSR management unit within agreed extent and timeframeSupporting 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 managerQualificationsLife science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilanceMinimum 1 year of work experience in pharmacovigilanceOrganization skills, including attention to detail and multitaskingManagement skills, including time and issue managementEnglish - advanced (spoken, written)Advanced literacy (MS Office)Additional InformationWhy PrimeVigilance?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 OfferTraining and career development opportunities internallyStrong emphasis on personal and professional growthFriendly, supportive working environmentOpportunity to work with colleagues based all over the world, with English as the company languageOur 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!QualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsWe look forward to welcoming your application.
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