Global Risk Management Plan Manager

hace 2 semanas


Barcelona, Barcelona, España Novartis A tiempo completo
About the Role

We are seeking a highly skilled Global Risk Management Plan Manager to join our team at Novartis. As a key member of our safety team, you will be responsible for managing and coordinating the development, review, and tracking of Safety Risk Management Plans (RMPs) to ensure they are of high quality and regulatory compliant.

Key Responsibilities
  • Manage the development and review of RMPs to ensure they meet regulatory requirements and are aligned with company processes.
  • Coordinate with cross-functional teams to ensure all necessary documents are included in the RMP annexes and available in the Document Management System.
  • Track and implement Health Authority feedback and assessment on RMPs.
  • Ensure timely submission and delivery of high-quality RMPs to Health Authorities.
  • Collaborate with the Safety Lead to update RMPs according to Health Authority requirements.
Requirements
  • At least 5 years of experience in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.
  • Proven ability to work with large cross-functional teams in complex projects.
  • Strong communication and teamwork skills.
  • Knowledge of worldwide regulatory requirements for drug registration and clinical drug development.
  • Fluent in spoken and written English, with understanding of another major language desirable.
Why Novartis

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We offer a range of benefits and rewards to support your personal and professional growth.



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