Pharmacovigilance Specialist / Deputy QPPV

About this role

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come

Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><div><p><b>Key Responsibilities:</b></p><ul><li>Act as Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) for Ukraine and Moldova, with involvement in and understanding of all local PV activities and processes</li><li>Maintain the local PV system in compliance with local legislation and global company standards</li><li>Manage and oversee ICSRs, including cases related to clinical trials and medical devices</li><li>Manage safety aggregate reports, including PBRERs, DSURs, A13 submissions, and other regulatory safety documentation</li><li>Coordinate DHPCs and other safety communications</li><li>Monitor safety information sources (medical literature, local regulatory authorities) and support local signal management activities</li><li>Participate in internal audits and regulatory inspections</li><li>Manage and oversee internal and external partners, including safety agreements and reconciliation activities</li><li>Monitor changes in local PV and regulatory legislation</li><li>Collaborate with regulatory authorities, direct market service providers, global teams, and external partners</li><li>Support cross-functional internal projects and initiatives</li><li>Conduct initial and refresher PV training sessions for internal and external stakeholders</li></ul><p><b>Requirements:</b></p><ul><li>English level: Intermediate+ / Upper-Intermediate (confident understanding of written and spoken communication, participation in business discussions, and communication with intern

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