SeniorPVAssociate

We 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. * Providing support to other activities undertaken by the project team on behalf of the client and the company * Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): * Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines * Performing ICSR follow up * SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) * Reconciliation (clinical, partners) * Personal data protection * Product Quality Complaint handling and interaction with Quality Assurance * Medical Information interaction * MedDRA and WHO coding * Database Outputs and Reports (including data for monthly reporting to clients) * Workflow & resource management * Support of PV processes related to the ICSR managem