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Medical Writer Ii
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Medical Writer II - homebased in Europe (aggregate report experience required) 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 DescriptionThe PrimeVigilance Medical Writer II position offers a unique opportunity to further develop your career in the field of drug safety medical writing.Key ResponsibilitiesIndependent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports- PSURs/PBRERs, PADERs, DSURs, risk management plans and other documents needed throughout the product's life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards.Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation.Support in all pharmacovigilance operations associated with medical writing.QualificationsBachelor's degree in healthcare or life sciences or other related disciplines. Master's or Doctoral degree preferred.Previous experience in Pharmacovigilance and aggregate report writing in industry.Ability to manage multiple and varied tasks and prioritize workload with attention to detail.Must be a strong team player.Fluency in English, an additional language is a benefit.Additional 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.We offer:Training and career development opportunities internally.Strong emphasis on personal and professional growth.Friendly, supportive working environment.Opportunity to work with colleagues based all over the world, with English as the company language.Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to joinQualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsCome and join us in this exciting journey to make a positive impact in patient's lives. We look forward to welcoming your application.
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