Senior Case Processing Oversight Manager
2 weeks ago
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 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 Educations Required BS/BA, RN, Pharmacist, or similar. Our 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. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL Do work that matters at CSL Behring
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Global Account Manager
1 week ago
EMEA, United Kingdom EDB Full time £80,000 - £120,000 per yearA Little About UsEDB provides a data and AI platform that enables organizations to harness the full power of Postgres for transactional, analytical, and AI workloads across any cloud, anywhere. EDB empowers enterprises to control risk, manage costs and scale efficiently for a data and AI led world. Serving more than 1,500 customers globally and as the...
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Associate Director, Clinical Trial Disclosure
2 weeks ago
EMEA, United Kingdom CSL Behring Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide....
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Senior Sales Engineer
3 days ago
EMEA, United Kingdom EDB Full time £60,000 - £120,000 per yearA Little About UsEDB provides a data and AI platform that enables organizations to harness the full power of Postgres for transactional, analytical, and AI workloads across any cloud, anywhere. EDB empowers enterprises to control risk, manage costs and scale efficiently for a data and AI led world. Serving more than 1,500 customers globally and as the...
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Senior Project Manager, R&D: Drug Development
2 weeks ago
EMEA, United Kingdom CSL Behring Full timeCSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide....
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Public Sector Account Executive
1 week ago
EMEA, United Kingdom EDB Full time £60,000 - £120,000 per yearA Little About UsEDB provides a data and AI platform that enables organizations to harness the full power of Postgres for transactional, analytical, and AI workloads across any cloud, anywhere. EDB empowers enterprises to control risk, manage costs and scale efficiently for a data and AI led world. Serving more than 1,500 customers globally and as the...
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Senior Software Engineer, AI
1 day ago
EMEA, United Kingdom Hostaway Full timeNOTE: This is a FULLY remote role, but the candidate must be within EMEA to collaborate with their team, peers, and internal customers. You do not have to be in the specific country or city shown in this listing, but please only apply if you are physically based within EMEA.Hostaway is a SaaS scale-up that is transforming the vacation rental industry. With...
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Global Head of Talent Acquisition
1 week ago
EMEA, United Kingdom Opswat Full time £120,000 - £180,000 per yearThe PositionThe Global Head of Talent Acquisition will lead and scale our global recruitment function to meet the evolving needs of a fast-growing, mission-critical organization. Reporting to the Global Head of Human Resources, you will be responsible for the strategy, operations, tools, and results of OPSWATs hiring engine across all functions and regions,...
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Senior Pre-Sales Solutions Engineer
1 week ago
EMEA| Remote, United Kingdom Deepgram Full time £80,000 - £120,000 per yearCompany OverviewDeepgram is the leading voice AI platform for developers building speech-to-text (STT), text-to-speech (TTS) and full speech-to-speech (STS) offerings. 200,000+ developers build with Deepgram's voice-native foundational models – accessed through APIs or as self-managed software – due to our unmatched accuracy, latency and pricing....
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Investment Banking Analyst 1, Services
1 week ago
EMEA, United Kingdom William Blair Full time £60,000 - £120,000 per yearExecute in-depth analyses to support new business development, transaction execution and the delivery of investment banking products and services to clients and prospects. Perform research and financial modeling, apply core valuation methods, and complete due diligence activities at the direction of the Investment Banking team lead. Work closely with client...
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Associate Director, Site Engagement Lead
2 weeks ago
EMEA, United Kingdom CSL Behring Full timeMake a meaningful impact by shaping how CSL partners with clinical research sites worldwide. At CSL, we’re driven by a single purpose: to deliver innovative therapies that improve patients’ lives. The Site Engagement Group plays a key role in achieving this mission by positioning CSL as a sponsor of choice - building strong, collaborative, and...