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Group Head, Global Aggregate Reports and Risk Management

hace 2 meses


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
About the Role

The Group Head, Global Aggregate Reports and Risk Management, leads a team of Senior Global Risk Management Plan Managers, 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 products and supported by complex stakeholder matrices.

Key Responsibilities
  1. Deliver High-Quality Results: Responsible for timely high-quality deliverables through direct involvement in processes or through assignments, considering individual workload, experience, location, business needs, and individual development needs. Interacts with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
  2. Lead and Develop a Team: Responsible for recruiting, developing, and retaining Senior Global RMP Managers, Senior Medical Writers, and AR&RM Analysts. Develops and implements an onboarding program for new hires. Provides operational and strategic guidance on RMP & AR processes, policy, templates, and training.
  3. Collaborate with Global Leadership: Member of the AR&RM Leadership Team. Collaborates with the Global Head of Aggregate Reports and Risk Management in setting the department's objectives and achieving them.
  4. Advise and Influence: Advises and influences the organization regarding Aggregate Reports and Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide, as well as for lifecycle management, through close connection with stakeholders and industry peers.
  5. Develop Tools and Processes: 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.
  6. Expertise and Representation: 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.
  7. Collaboration and Representation: Acts as AR&RM SME for assigned collaborations at early stages of partnerships, e.g., integrations, mergers, and acquisitions. Influences these collaborations beyond Patient Safety, in global and local cross-functional and cross-divisional aspects of RMP, e.g., Regulatory Affairs, Marketing, Countries, which impact worldwide launches.
  8. Regulatory Compliance: Evaluates the impact and ensures compliance in collaboration with OPEX of worldwide regulations and industry practices on current AR&RM plans strategy, processes, and tools, e.g., ensures the templates and internal guidance on strategy are in accordance with new/changing regulations.
  9. Metrics and Quality: Designs, develops, and maintains metrics to monitor quality of RMPs & AR, and escalates to the Head of department, QPPV, PS&PV leadership, and cross-functional boards any potential risk and issues.
  10. Training and Development: Provides input into the development of regular and up-to-date AR & RM training to the organization, namely SMT/GPTs, Medical Safety, Regulatory, Quantitative Safety and Epidemiology, Clinical, Medical Affairs.
  11. Deputy Role: Deputizes for the Global Head of Aggregate Reports and Risk Management, e.g., MSRB for AR & RMP-related aspects, and strategic initiatives.