Senior Case Processing Oversight Manager

Vor 4 Tagen

Opfikon, Schweiz CSL Vollzeit

The position is part of a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.Key ResponsibilitiesOversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documentsOversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety OfficersServe as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs, GDLs, work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.Supporting the investigation / assessment of ICSR compliance activities where requiredReg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.Audit and inspection readiness including corrective & preventive action (CAPA) management.SME for the initiatives or projects in the context of case processingSkills and Experience RequiredMinimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.Direct experience authoring/ updating SOPs, work instructionsQualifications and Educations RequiredBS/BA, RN, Pharmacist, or similar. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you.

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