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Medical Writer I
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.We are PrimeVigilance (part of Ergomed PLC), 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.Job DescriptionWe are looking for a pharmacovigilance medical writer to join our team. The Medical Writer will be responsible for medical writing including:PADERsACOsDSURsRMPsQC and review of all written output from the operations team as requiredSupporting the project managers to determine scheduling of the aggregate reports for which they are responsibleIn conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templatesComplete quality documentation of aggregate reportsAttending kick off meetings with new clients as requiredAttending audits and inspections as requiredProviding aggregate report trainingQualificationsMD, pharmacy or Life Science degree (Masters or PhD is desirable)Strong previous experience in Pharmacovigilance (case processing, signal detection or risk management)within ideally a CRO environmentAbility to manage multiple and varied tasks and prioritize workload with attention to detailAbility to effectively train and mentor Associate Medical WritersMust be a strong team playerFluency in English, an additional language is a benefitAdditional InformationWhy PrimeVigilanceWe 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
