OverviewJoin to apply for the Pharmacovigilance Officer (senior level position) role at PrimeVigilance.PrimeVigilance is a specialised mid-size pharmacovigilance service provider established in 2008 (part of Ergomed Group). We are global with staff across Europe, North America and Asia, covering Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.Job DescriptionAt PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability. You will work with teams of different sizes, from small clinical trial to large, generic post-marketing teams. We are looking for proactive, capable and motivated individuals who aim to surpass targets.The PV Officer should be a Life science / biomedical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated strong experience with several years in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.ResponsibilitiesProcessing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and client requirements and timelines. Cover all steps of a workflow cycle, except Medical Review.Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).Mentoring and training of new and more junior employees within the department, including procedure optimization and development.QualificationsLife science / biomedical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.Demonstrated case processing experience.Time and issue management, delegation, organization and multitasking skills with good attention to detail.Strong interpersonal and communication skills.Advanced English skills, both verbal and written, at least C1.Additional InformationWhy PrimeVigilance?We 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. Our people are our greatest strength, leading to success in improving the lives of those around us.We OfferTraining and career development opportunities internallyStrong emphasis on personal and professional growthFriendly, supportive working environmentOpportunity to work with colleagues based all over the world, with English as the company languageOur core values are key to how we operate. If you feel they resonate with you, PrimeVigilance could be a great company to join:QualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsWe look forward to welcoming your application.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesPharmaceutical ManufacturingGet notified about new Drug Safety Officer jobs in Rome, Latium, Italy.
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