Job Description

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 patients lives. The Senior Medical Monitor within the ERGOMED Global Medical Affairs is responsible for providing medical monitoring and medical safety expertise to enable high quality and efficiency in the ERGOMED Global Medical Affairs and providing Medical Monitoring tasks including those of higher complexity. ROLE AND RESPONSIBILITIES Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects 24/7 medical consultancy support to investigators and project team Monitoring of patients safety and well-being: Detection of trends and outliers Signal detection Eligibility check Review of selected laboratory parameters Protocol deviations review with proposed grading from medical/safety perspective Review of subject discontinuation list Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well as an indication) Medical review/creation of case/narratives and participating in the SAE reconciliation as support to the Safety Department Regular presentations of MM reports to the study team Medical Review of patient data Medical input to the study-related documents (including the preparation of the MM plan) Participation in Kick-off Meetings, Investigator Meetings, and other study-related meetings, including participation at the safety committee meetings (DSMB, IDMC, and SRC meetings) and Presentation of the safety data Training of the project team and investigators on the indication, IMP, AxMP, and other medical aspects of the study Reviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of events if appropriate Overview of SP activities and review of the SP visit reports QUALIFICATIONS Medical Doctor degree. Additional board certification and/or medical specialty are appreciated and optional. Practical clinical research experience Highly organized, with strong interpersonal skills Proven efficiency in timely delivery Proficiency in all MS Office applications including Microsoft Word, Excel, and PowerPoint, Practical use of Microsoft Teams and SharePoint is needed Why Should You Apply? You want be involved in a wide range of interesting projects and studies You want your achievements and hard work to be recognized You want to work for a growing company where you can progress in your career and where there are opportunities for advancement. You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Ergomed

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