PV Officer

hace 1 mes

España Ergomed Group 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 trial, 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 be a Life science / bio medical background graduate or have other 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.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. As a key member there is an expectation to effectively 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

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