Senior Global Risk Management Plan Director
hace 2 días
The 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, together with the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT), including for new submissions and innovative medicines, aligned with business priorities.
This role will guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrices.
The Senior Global Risk Management Plan Manager will lead initiatives related to Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.
This role will represent the Risk Management 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, including for new submissions and innovative medicines.
The Senior Global Risk Management Plan Manager will partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs.
This role will mentor new hires in the AR RM team as RMP expert.
The Senior Global Risk Management Plan Manager will deputize for the Team Lead or Group Head ARRM in defined meetings and initiatives.
Responsibilities- Drive the development of a robust and feasible RMP strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT, including for new submissions and innovative medicines, aligned with business priorities.
- Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrices.
- Lead initiatives related to Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.
- Represent the Risk Management 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, including for new submissions and innovative medicines.
- Partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs.
- Mentor new hires in the AR RM team as RMP expert.
- Deputize for the Team Lead or Group Head ARRM in defined meetings and initiatives.
- 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.
- Knowledge of 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 area to the level required for delivering successfully RMPs and aggregate safety reports.
- Solid Medical/Scientific writing and verbal skills.
- Fluent in spoken and written English.
- Understanding in another major language (e.g. French, German, Spanish) desirable.
- Scientific Degree required.
- Advanced degree (Masters, PharmD or PhD) desirable.
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Barcelona, Barcelona, España Innovative Medicines A tiempo completo### Job Summary We are seeking a highly skilled and experienced professional to lead our Global Risk Management team. As the Global Risk Management Lead, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies. ### Key Responsibilities *...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completo### Job Summary We are seeking a highly skilled and experienced professional to lead our Global Risk Management team. As the Global Risk Management Lead, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies. ### Key Responsibilities *...
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Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryAs a Group Head, Global Aggregate Reports & Risk Management, 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. You will work closely with cross-functional teams...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in developing robust Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Your Key Responsibilities:Develop and implement high-quality Risk Management Plans and...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in developing robust Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Your Key Responsibilities:Develop and implement high-quality Risk Management Plans and...
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