Senior Case Processing Oversight Manager
2 weeks ago
Senior Case Processing Oversight Manager 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. This position is to be based onsite (hybrid working) in Maidenhead, UK, Zurich, CH, or King of Prussia, US. Key Responsibilities Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents. Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers. Serve 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 required. Reg 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 processing. Skills and Experience Required Minimum 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 instructions. Qualifications and Education Required BS/BA, RN, Pharmacist, or similar. #J-18808-Ljbffr
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Global PV Case Processing Oversight Lead
2 weeks ago
Maidenhead, United Kingdom CSL Full timeA global biopharmaceutical company is seeking a Senior Case Processing Oversight Manager to lead oversight activities related to case processing. This role requires a minimum of 10 years in Clinical Trial and Post-marketing Pharmacovigilance, as well as proficiency in global regulatory requirements. You will serve as a Subject Matter Expert and drive...
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Senior Case Processing Oversight Manager
1 week ago
Maidenhead, United Kingdom CSL Full timeThe 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. This position is to be based onsite (hybrid working) in Maidehead UU, Zurich CH, or King of Prussia (US) Key Responsibilities Oversee...
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Senior Case Processing Oversight Manager
7 days ago
Maidenhead, United Kingdom CSL Behring Full timeThe 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...
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Senior Case Processing Oversight Manager
1 week ago
Maidenhead, United Kingdom CSL Full timeThe 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.This position is to be based onsite (hybrid working) in Maidehead UU, Zurich CH, or King of Prussia (US)Key ResponsibilitiesOversee...
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Senior Case Processing Oversight Manager
1 week ago
Maidenhead, United Kingdom CSL Plasma Full timeThe 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...
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Senior Case Processing Oversight Manager
2 weeks ago
Maidenhead, United Kingdom CSL Plasma Full timeThe 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 Responsibilities Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents...
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Senior case processing oversight manager
2 weeks ago
Maidenhead, United Kingdom CSL Behring Full timeThe 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...
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Senior Case Processing Oversight Manager
2 weeks ago
Maidenhead, United Kingdom CSL Behring Full timeThe 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...
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Senior Case Processing Oversight Manager
7 days ago
Maidenhead, United Kingdom CSL Behring Full timeThe 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...
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Senior Case Processing Oversight Manager
5 days ago
Maidenhead, United Kingdom CSL Behring Full timeThe 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.Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Key Responsibilities...
