General Manager logistics overseeing efficient warehouse operations at GXO, ensuring high standards of productivity and safety as part of a global supply chain solution.
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
Salary
Not specified
Degree requirement
Location requirements
MGRP Manager IT - Strategieberatung providing consulting for IT strategy and solutions development. Leading a team while driving client relationships and business development efforts.
Leitender Techniker für Telekommunikationsnetze bei 2W - COM GmbH in Isernhagen. Verantwortung für Projektleitung und fachliche Ansprechpartnerrolle in einem innovativen Unternehmen.
Foster Care Case Manager at LFCS providing child welfare services and case management support. Building relationships with families and ensuring client records are maintained accurately.
Healthcare Facilities and Energy Manager overseeing energy consumption and Central Energy Plant operations. Relocation assistance available for multiple U.S. locations: Midland, Springfield, Potsdam, and Portland.
Healthcare Facilities and Energy Manager responsible for reviewing energy consumption and overseeing Central Energy Plant operations for multiple healthcare facilities. Relocation assistance available for selected locations in the US.
Commercial Manager overseeing negotiations and contract terms across Environmental Services projects. Collaborating with teams to mitigate risks and deliver client satisfaction in North America.
Commercial Manager in Environmental Services for Stantec overseeing negotiations and project delivery, mitigating financial risks through collaboration and excellence in contract management.
Manager leading eDiscovery project execution and team supervision in Kroll’s India - based delivery team. Responsibilities include workload management, stakeholder communication, and workflow optimization.
Advertising Systems and Automation Manager at Hearst Magazines designing and managing operational infrastructures. Collaborating with multiple departments to optimize digital advertising workflows and ensure efficiency.