Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, âquest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Provide leadership and support for UK based Case Management Team Ensure effective co-ordination of AE flow through the case management workflow in coordination with Swiss based teamEnsure process conformity with applicable regulations and Celgene standards and ICSR conventionsEstablishment, maintenance and monitoring of key performance indicators (KPI)Drive Case Management process enhancement and team developmentCase Management Operations Performance, Metrics & Resourcing- Lead goal setting, Key Performance Indicators (KPIs) development and performance management within the GDSRM International Case Management Operations team - Support central and where applicable affiliate resource calculation and contribute resourcing strategies including hiring and supervision of temporary contract staff- Liaison with HR Business Partners service providers including resourcing for temporary staff- Establish team metrics to support resourcing and contribute to the development of resource calculation tools- Responsible for the definition and generation of metrics addressing work volumes, compliance, quality and productivity- Manage the root cause analysis of issues revealed by review of metrics- Responsible for the determination of actions stemming from metrics review- Act as a key liaison with internal and external stakeholdersWorkflow Management - Ensure team conformance with internal and external AE timelines- Oversee the daily flow of cases through Aris WF operating system.- Resolution of case prioritization issues- Co-ordinate workload balancing issues- Provide input to the resolution of issues relating to case complexity- Manage flow of cases outside of standard workflow as needed- Participate in notifying AE Management of department resources who fail to adhere to workflow business rules- Manage corrective actions stemming from internal or external AE case reports review- Oversee AE case report inquiries received from AE management team and LDSOs- Oversee AE case report inquiries received from NCA and other Celgene stakeholders- Coordinate case assignment and completion to meet data lock points.- Coordinate the management of ICSRs received as a batchOrganized data collection - Support and contribute to the fulfilment of Celgeneâs compliance with organized data collection programs conducted by other departments (i.e. Market Researches, PSP, etc) including assisting with reviewing of project material across Hematology/Oncology and Immunology and Inflammation franchisesRegulatory Reportability, Distribution & Submission- Provide leadership and oversight to ensure compliance with global, regional and local expedited reporting requirements.- Support ICSR distribution process through workload allocation and team availability - reasons for cases outside the internal processing as well as regulatory timelines and implement corrective and preventive actions as appropriateQuality Assurance- Ensuring optimal quality of case reports internally (e.g. EOI quality check) through monitoring and continuous improvement - Contribute to identifying root causes, action items and action plans to correct quality issues stemming from internal or external review- Facilitate communication of quality and performance findings and cooperate with Safety Operations to address corrective and preventative actions as needed- Contribute to the development of processes and tools to ensure high quality safety data input/output in compliance with regulatory standardsTrial Safety Support- Communicate with Trials Safety Team to identify and resolve SAE reporting issues- Contribute to ensuring adherence of outsourced studies to dept. standards- Contributes to SAE reconciliation - Contribute to reviewing SAE reporting plans if required- Supporting GDSRM International Pharmacovigilance Operations- Collaboration with GDSRM International Pharmacovigilance Operations Team and maintain effective level of communication and collaboration with Affiliate Pharmacovigilance TeamsPharmacovigilance (approved products)- Ensure timeliness and quality of processing of ICSRs to meet applicable data base locks for Aggregate Reports including PSURs, PBRER and DSURs across product franchises. Compliance, Standards & Project Management- Participate in the creation and maintenance of Celgene Case Management policies practices and procedures- Lead in the establishment and execution of Case Management projects in support of ongoing process evolution and improvement in line with internal and external driversTeam Development & Training- Identify training needs of internal team as well as external customers & feeder groups- Participate in the development of required training needsInternal GDSRM International Case Management Operations Development- Contribute to GDSRM Case Management Goal Setting- Execute Performance Management for Team - Coordinate team participation and input in event discussion meetings- Conduct 1:1 Meetings with Team Members and support IDP development- Hire, orientate, manage, mentor, and develop staff- Conduct team meetingsProject Management- Lead or contribute to projects identified and designed to improve ICSR management operations including impact assessment and implementation of new legislative requirements Continuous Improvement & Innovation- Participate in continuous improvement and supporting evolution and innovation within Case Management. - Contribute to root cause analysis of process issues & corrective actions, prioritize, plan improvements including ad-hoc topics as well as those originating through Audit and regulatory Inspection.- Support Training Manager to identify training needs and contribute to facilitate them either by providing/developing educational material or participating in organization of TrainingAudit and Regulatory Inspection- Acts as SME for both internal audits and Regulatory Authority inspections- Support root cause analysis and CAPA according to completion schedule- Resource for document retrieval and quality assurance of requested documents during inspectionsPreferred Role Qualifications, Experience, Knowledge & CompetenciesThe knowledge and skills necessary to perform the duties of this position are typically acquired through the following combinationof education and experience or the equivalent.Qualifications- Minimum of B.Sc. or the equivalent combination of relevant education or professional experienceExperience - Eight (8) years pharmaceutical/biotechnology industry experience- Six years (6) Drug Safety experience Knowledge- Excellent knowledge of pharmacovigilance regulatory requirements (Safety and Risk management i.e. FDA, EMA and ICH guidelines)- Ability to influence senior leaders in the Celgene business without authority - Clinical knowledge of therapeutic area patient populations and drug class: oncology and I&I experience preferred- Proficiency in technical safety systems including ARISg and medical coding- Knowledge of aggregate safety data utilization- Good project management skillsCompetencies & Behaviours - Team leadership, people management and development/empowerment- Inspires and motivates- Fosters team work - Excellent influencing and leadership skills- Excellent written and verbal communication skills including presentation skills- Excellent interpersonal skills- Ability to identify and communicate issues within department and across geographies: Matrix management- Ability to resolve conflict- Stakeholder advocacy; promote open communication and build external relationships- Applies profound technical expertise- Effective Organisation and planning; ability to multitask and prioritize- Strong attention to detail, team work and initiative- Solution oriented with a global mindset- Strong analytical skills- Fosters a culture of Curiosity and Continuous Learning
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.