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Responsible Person for Pharmacovigilance Job details Work location: Mesagne (BR), Italy, or fully remote ClinOpsHub S.r.l., founded in 2014 by Stefano Lagravinese, is a Contract Research Organization (CRO) self-certified with AIFA since 2019. We are a recognized partner in the Clinical Research sector, providing services to pharmaceutical companies, investigational sites, laboratories, and other CROs, with a strong focus on quality, innovation, and professional development. Role and objectives We are looking for an experienced Responsible Person for Pharmacovigilance with a strong background in pharmacovigilance activities within clinical trials. The successful candidate will be responsible for coordinating and overseeing ClinOpsHub’s pharmacovigilance activities, ensuring compliance with applicable regulatory requirements and contractual agreements with Sponsors. The role involves managing the Pharmacovigilance Quality System, overseeing adverse event management and reporting processes, and coordinating personnel involved in clinical trial safety activities.
The Responsible Person for Pharmacovigilance will collaborate with internal teams and external stakeholders, providing subject matter expertise in pharmacovigilance across multiple projects. Main responsibilities The Responsible Person for Pharmacovigilance will be responsible for the following activities: * Managing and maintaining ClinOpsHub’s Pharmacovigilance Quality System, ensuring compliance with applicable regulatory requirements and overseeing the maintenance and updating of relevant Standard Operating Procedures (SOPs). * Managing ClinOpsHub’s registration in EudraVigilance for activities performed on behalf of Sponsors, as required by individual projects. * Performing pharmacovigilance activities as defined in contractual agreements, in compliance with Regulation (EU) No. 536/2014 and applicable guidelines. * Ensuring that Service Provider Agreements and Safety Management Plans (SMPs) are aligned wit
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