Senior Manager, Alliance Management leading processes to maximize value of Genmab’s pharmaceutical partnerships. Focusing on governance, operational excellence, and strategic alignment.
About the role
- Senior Case Processing Oversight Manager overseeing global regulatory updates and case handling processes at CSL Behring. Collaborating with cross-functional teams to ensure compliance and optimize case management operations.
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.
Requirements
- 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.
Benefits
- We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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