Global Risk Management Plan Manager
hace 2 semanas
The Global Risk Management Plan Manager plays a critical role in ensuring the timely preparation, development, and finalization of high-quality and regulatory-compliant Safety Risk Management Plans (RMP). This position requires strong collaboration and communication skills to work effectively with cross-functional teams, including medical safety physicians, clinical development teams, and regulatory affairs experts.
Key Responsibilities- Support the Global Product Safety Leader (GPSL) and designated medical writer in the preparation and development of RMPs.
- Coordinate activities from different line units to ensure all documents required to support the RMP main document are included in the RMP annexes and available in the Document Management System.
- Manage logistical aspects related to the timely development of safety RMP annexes and work with authors to ensure RMP annexes content meets Novartis and Health Authorities (HA) requirements.
- Review RMPs to ensure consistency and regulatory compliance of RMP sections and annexes.
- Track HA feedback and assessment on RMP and ensure HA requirements are implemented as required.
- 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.
- Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.
- Proven ability to interpret, discuss efficacy and safety data relating to multiple therapeutic areas.
- Solid Medical/Scientific writing and verbal skills.
- Fluent in spoken and written English; understanding in another major language (e.g. French, German, Spanish) desirable.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completoJob Description**Global Risk Management Plan Manager**The Global Risk Management Plan Manager plays a critical role in ensuring the timely and high-quality development of Safety Risk Management Plans (RMPs) to support the company's products. This position is responsible for coordinating activities across different line units to ensure all documents required...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completoJob Description**Global Risk Management Plan Manager**The Global Risk Management Plan Manager plays a critical role in ensuring the timely and high-quality development of Safety Risk Management Plans (RMPs) to support the company's products. This position is responsible for coordinating activities across different line units to ensure all documents required...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role:The Global Risk Management Plan Manager provides critical support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely...
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Global Risk Management Plan Manager
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role:The Global Risk Management Plan Manager provides critical support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryAs a Global Risk Management Plan Manager at Novartis, you will play a critical role in ensuring the timely development and implementation of high-quality Safety Risk Management Plans (RMPs) that meet regulatory requirements. Your expertise will be instrumental in guiding the Global Product Safety Leader and key authors to ensure that commitments...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryAs a Global Risk Management Plan Manager at Novartis, you will play a critical role in ensuring the timely development and implementation of high-quality Safety Risk Management Plans (RMPs) that meet regulatory requirements. Your expertise will be instrumental in guiding the Global Product Safety Leader and key authors to ensure that commitments...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager plays a critical role in ensuring the safety and efficacy of Novartis products. This position is responsible for the development, implementation, and maintenance of Safety Risk Management Plans (RMPs) to mitigate potential risks associated with our products.The ideal candidate will have a strong...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager plays a critical role in ensuring the safety and efficacy of Novartis products. This position is responsible for the development, implementation, and maintenance of Safety Risk Management Plans (RMPs) to mitigate potential risks associated with our products.The ideal candidate will have a strong...
-
Global Risk Management Plan Manager
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager will provide support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely...
-
Global Risk Management Plan Manager
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager will provide support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely...
-
Global Risk Management Plan Manager
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager plays a critical role in ensuring the safety and efficacy of our products. This position is responsible for managing the development, review, and tracking of Safety Risk Management Plans (RMPs) to ensure regulatory compliance and high-quality documentation.Key ResponsibilitiesSupport the Global Product...
-
Global Risk Management Plan Manager
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager plays a critical role in ensuring the safety and efficacy of our products. This position is responsible for managing the development, review, and tracking of Safety Risk Management Plans (RMPs) to ensure regulatory compliance and high-quality documentation.Key ResponsibilitiesSupport the Global Product...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob DescriptionJob Summary: We are seeking a highly skilled Global Risk Management Plan Manager to join our team at Novartis. The successful candidate will be responsible for providing support to medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans.Key Responsibilities:Develop and...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob DescriptionJob Summary: We are seeking a highly skilled Global Risk Management Plan Manager to join our team at Novartis. The successful candidate will be responsible for providing support to medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans.Key Responsibilities:Develop and...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleWe 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...
-
Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleWe 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...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryThe Global Risk Management Plan Manager plays a critical role in ensuring the company's drug, biologics, or medical devices surveillance program is effectively monitored and audited. This includes the intake, evaluation, processing, and follow-up on adverse reports. The successful candidate will participate in the resolution of any legal liability...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryThe Global Risk Management Plan Manager plays a critical role in ensuring the company's drug, biologics, or medical devices surveillance program is effectively monitored and audited. This includes the intake, evaluation, processing, and follow-up on adverse reports. The successful candidate will participate in the resolution of any legal liability...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completoJob Description**Job Summary**We are seeking a highly skilled Global Risk Management Plan Manager to join our team at the Healthcare Businesswomen'S Association. The successful candidate will be responsible for managing and coordinating the development of Safety Risk Management Plans (RMPs) to ensure regulatory compliance and high-quality documents.Key...
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Global Risk Management Plan Manager
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completoJob Description**Job Summary**We are seeking a highly skilled Global Risk Management Plan Manager to join our team at the Healthcare Businesswomen'S Association. The successful candidate will be responsible for managing and coordinating the development of Safety Risk Management Plans (RMPs) to ensure regulatory compliance and high-quality documents.Key...
