Global Head of Aggregate Reports and Risk Management

hace 20 horas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

About the Role: As the Global Head of Aggregate Reports and Risk Management at Novartis Farmacéutica, you will lead 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 high-priority products/therapies. Your expertise will be crucial in aligning these strategies with the benefit-risk profile of the products and supporting complex stakeholder matrices.

Your Key Responsibilities Include:

  1. Deliver High-Quality Results: You will be responsible for timely and high-quality deliverables, either through direct involvement or through assignments, taking into consideration individual workload, experience, location, business needs, and individual development needs.
  2. Collaborate with Cross-Functional Teams: You will interact with Global Product Teams and Functions (e.g., Global Product Heads, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.
  3. Align Risk Management Strategies: You will align the support provided by Global (Sr) RMP Managers, (Sr) Medical Writers, and AR&RM Analysts to the Global teams in developing and maintaining Safety RMPs, RMP strategies, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
  4. Lead and Develop a Team: You will be responsible for recruiting, developing, retaining (Sr) Global RMP Managers, (Sr) Medical Writers, and AR&RM Analysts, and developing and implementing an onboarding program for new hires.
  5. Provide Operational and Strategic Guidance: You will provide operational and strategic guidance on RMP & AR processes, policy, templates, and training.
  6. Drive Team Objectives: You will be responsible for AR & RM team objectives according to company and department priorities, development plans, and ongoing feedback on performance of direct reports.
  7. Contribute to Leadership Team: You will be a member of the AR&RM Leadership Team, collaborating with the Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
  8. Advise on Regulatory Affairs: You will advise and influence the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes relevant for product submissions and launches worldwide as well as for lifecycle management by close connection with stakeholders and industry peers.
  9. Develop Tools and Guidelines: You will guide 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.


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists 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...


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists 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...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans (RMPs) and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans (RMPs) and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head of Risk Management and Aggregate Reports is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role is critical in ensuring the company's compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Lead a team...


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head of Risk Management and Aggregate Reports is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role is critical in ensuring the company's compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Lead a team...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management will lead 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 high-priority products/therapies. This role will be responsible for ensuring alignment with...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management will lead 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 high-priority products/therapies. This role will be responsible for ensuring alignment with...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Risk Management and Aggregate Reports will lead a team of experts in developing and implementing robust risk management strategies and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements and industry best practices.Key ResponsibilitiesDevelop and...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Risk Management and Aggregate Reports will lead a team of experts in developing and implementing robust risk management strategies and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements and industry best practices.Key ResponsibilitiesDevelop and...


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis, responsible for overseeing the development and implementation of robust risk management plans and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements, industry...


  • Barcelona, Barcelona, España Novartis A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis, responsible for overseeing the development and implementation of robust risk management plans and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements, industry...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role requires a deep understanding of global regulatory requirements and the ability to develop and implement effective risk management strategies.Key...


  • Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    About the RoleThe Global Head of Aggregate Reports and Risk Management is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role requires a deep understanding of global regulatory requirements and the ability to develop and implement effective risk management strategies.Key...


  • Barcelona, Barcelona, España Innovative Medicines A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management will lead a team of Senior Risk Management Plan Managers, Medical Writers, and Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products and therapies. This role will align with the benefit-risk profile of products and be...


  • Barcelona, Barcelona, España Innovative Medicines A tiempo completo

    About the RoleThe Global Head, Aggregate Reports and Risk Management will lead a team of Senior Risk Management Plan Managers, Medical Writers, and Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products and therapies. This role will align with the benefit-risk profile of products and be...


  • Barcelona, Barcelona, España Innovative Medicines A tiempo completo

    About the RoleThe 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...