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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and Senior Medical Writers and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and Senior Medical Writers and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the...
Group Head, Global Aggregate Reports
hace 2 meses
.Job ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.About the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a group of Senior Global Risk Management Plan Managers as well as Senior Medical Writers and AR&RM Analysts in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high priority products/therapies, aligned with the benefit-risk profile of the products and supported by complex stakeholder matrixes.Your key responsibilities include:Responsible for timely high-quality deliverables either through direct involvement in processes or through assignments considering individual workload, experience, location, business needs, and individual development needs. Interacts with GPTs and Functions (e.G., GPH, HPS, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.Responsible for recruiting, developing, and retaining (Sr) Global RMP Managers/(Sr) Medical Writers/AR&RM Analysts, developing and implementing an onboarding program for new hires. Provides operational and strategic guidance on RMP & AR processes, policy, templates, and training.Member of the AR&RM Leadership Team. Collaborates with Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.Advises and influences the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide as well as for lifecycle management.Guides a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, working practices and guidelines, implementation of regulatory guidance, and Safety RMP project management.Acts as AR&RM Subject Matter Expert (SME) in inspections and audits, including handling of pre-inspection/audit requests, participating in interviews with inspectors/auditors, and supporting CAPAs.Acts as AR&RM SME for assigned collaborations at early stages of partnerships, influencing these collaborations beyond Patient Safety.Represents AR&RM in MSRB, GLC, GPTs & SMTs and other relevant boards/teams and provides expert opinion as required
