PharmacovigilancePhysician/II

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. 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. For the Client: * To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. * To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues * To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy * To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings * To cooperate in the preparation of and provide input in Risk Management Plans * Supporting the preparation of responses to regulatory authority requests * Signalling * Reviewing line listings * Participating in signal detect