Senior Global Risk Management Plan Director
hace 1 semana
As a Senior Global Risk Management Plan Manager at Federal Management System, Inc., you will guide the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management. You will provide strategic support to new submissions and innovative products, ensuring that documents are of high quality, regulatory compliant, and logistics and distribution are handled in an appropriate and timely manner.
About the Role
The Senior Manager Aggregate Reporting and Risk Management will be responsible for the development of a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT. This includes driving the development of a robust and feasible RMP strategy, guiding strategic decisions, designing a robust worldwide implementation plan, and leading initiatives related to Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management.
Your Key Responsibilities
* Develop a robust and feasible RMP strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT.
* Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy.
* Lead initiatives related with Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management.
* Represent the RM function in the Safety management team, working in close collaboration with the Safety Lead, Regulatory and other team members of the SMT/GPT (Clinical, Medical Affairs, Epidemiology, Biostatistics, Clinical Pharmacology, and Marketing, etc.) for the risk minimization activities planning and defining of effectiveness.
* Partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs.
Experience/Professional Requirement
* At least 7 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs, with 3 or more years expert knowledge in safety risk management.
* Proven ability to work with large cross-functional teams in complex projects, including new submissions and innovative medicines. Has demonstrated teamwork and effective communication skills. Partners with other line functions and establishes effective relationships with stakeholders at all levels.
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Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will guide the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, including strategic support to new submissions and innovative products.This role will provide support to the Safety Lead in the management,...
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Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will lead the development of a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, in collaboration with the Safety Lead and the SMT/GPT. This includes new submissions and innovative medicines, aligned with business priorities.The successful...
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