Senior Global Risk Management Plan Manager
hace 3 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, in collaboration with the Safety Lead and the SMT/GPT. This includes new submissions and innovative medicines, aligned with business priorities.
The successful candidate will guide strategic decisions and design a robust worldwide implementation plan of the RMP strategy, navigating complex stakeholder matrices. They 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.
The Senior Global Risk Management Plan Manager will represent the RM function in the Safety management team, working closely with the Safety Lead, Regulatory, and other team members of the SMT/GPT (Clinical, Medical Affairs, Epidemiology, Biostatistics, Clinical Pharmacology, and Marketing, etc.) for risk minimization activities planning and defining of effectiveness, including for new submissions and innovative medicines.
They will partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs. The successful candidate will also mentor new hires in the AR RM team as RMP expert and deputize for the Team Lead or Group Head ARRM in defined meetings and initiatives.
Key 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.
- Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines.
- Lead initiatives related with Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.
- Represent the RM function in the Safety management team, works 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.
- Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.
- Education (minimum/desirable): Scientific Degree required. Advanced degree (Masters, PharmD or PhD) desirable.
Novartis is a global healthcare company that is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe new insights, perspectives, and groundbreaking solutions can be found at the intersection of medical science and digital innovation.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
At Novartis, we are committed to helping people with disease and their families. We believe that our work can make a difference in people's lives, and we are passionate about creating a brighter future together.
-
Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Federal Management System, Inc. A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager 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. This includes strategic support to new submissions and innovative products. The successful...
-
Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Federal Management System, Inc. A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager 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. This includes strategic support to new submissions and innovative products. The successful...
-
Senior Global Risk Management Plan Manager
hace 3 días
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,...
-
Senior Global Risk Management Plan Manager
hace 3 días
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,...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & 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 high-priority products/therapies.Key ResponsibilitiesDevelop and implement Risk Management...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & 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 high-priority products/therapies.Key ResponsibilitiesDevelop and implement Risk Management...
-
Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager 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, including strategic support to new submissions and innovative products.This role will provide...
-
Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager 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, including strategic support to new submissions and innovative products.This role will provide...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoJob SummaryWe are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports & Risk Management team. As the Group Head, you will be responsible for developing and implementing robust Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.Key ResponsibilitiesLead a team of Senior...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoJob SummaryWe are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports & Risk Management team. As the Group Head, you will be responsible for developing and implementing robust Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.Key ResponsibilitiesLead a team of Senior...
-
Global Risk Management Plan Manager
hace 4 semanas
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleThe 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 (RMPs). This position provides support to the Global Product Safety Leader (GPSL) and designated medical writers in managing, coordinating, and...
-
Global Risk Management Plan Manager
hace 4 semanas
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleThe 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 (RMPs). This position provides support to the Global Product Safety Leader (GPSL) and designated medical writers in managing, coordinating, and...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports Risk Management, leads a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and ARRM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Key ResponsibilitiesTimely delivery of high-quality Risk...
-
Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports Risk Management, leads a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and ARRM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Key ResponsibilitiesTimely delivery of high-quality Risk...
-
Senior Risk Management Strategist
hace 3 días
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleAs a Senior Global Risk Management Plan Manager, you will play a critical role in guiding the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management. This includes strategic support to new submissions and innovative products, as well as the management,...
-
Senior Risk Management Strategist
hace 3 días
Madrid, Madrid, España Innovative Medicines A tiempo completoAbout the RoleAs a Senior Global Risk Management Plan Manager, you will play a critical role in guiding the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management. This includes strategic support to new submissions and innovative products, as well as the management,...
-
Risk Management Associate
hace 1 mes
Madrid, Madrid, España Global A tiempo completoAbout the Role:The Scorecard Team at S&P; Global is seeking a highly skilled Risk Management Associate to join our team of credit risk management professionals. As a Risk Management Associate, you will play a key role in delivering credit risk management services to clients, including analytical support, training, and credit risk assessment solutions.The...
-
Risk Management Associate
hace 1 mes
Madrid, Madrid, España Global A tiempo completoAbout the Role:The Scorecard Team at S&P; Global is seeking a highly skilled Risk Management Associate to join our team of credit risk management professionals. As a Risk Management Associate, you will play a key role in delivering credit risk management services to clients, including analytical support, training, and credit risk assessment solutions.The...
-
Senior Risk Management Strategist
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoAbout the RoleThis is a senior-level position within the Safety Management Team at Novartis, a leading pharmaceutical company. The successful candidate will be responsible for guiding the team on Good Pharmacovigilance Practices and other regulatory requirements for Safety Risk Management.Key ResponsibilitiesDevelop and implement a robust Risk Management...
-
Senior Risk Management Strategist
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoAbout the RoleThis is a senior-level position within the Safety Management Team at Novartis, a leading pharmaceutical company. The successful candidate will be responsible for guiding the team on Good Pharmacovigilance Practices and other regulatory requirements for Safety Risk Management.Key ResponsibilitiesDevelop and implement a robust Risk Management...
