Kmi672 | Pv Officer

hace 4 semanas


Madrid, España Primevigilance A tiempo completo

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. If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trials to large, generic post-marketing teams.We are always looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them. The PV Officer should have a life science/bio medical background or another healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.) and have demonstrated experience 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. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include:Processing 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 in accordance with client-specific requirements and timelines.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/bio medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.Demonstrated case processing experience; ARGUS experience preferred.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.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 joinCore Values:QualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsWe look forward to welcoming your application.#J-18808-Ljbffr


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