Senior Manager, Global Patient Safety
4 weeks ago
We are seeking a highly skilled and experienced Senior Manager, Global Patient Safety to join our team at Regeneron. As a key member of our Global Patient Safety team, you will be responsible for leading the initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, collaborators, and internal destinations in compliance with global regulations and contractual obligations.
Key Responsibilities- Contribute to intake responsibilities for Argus events, including all aspects of ICSR submission start-up process
- Track and monitor ICSR timelines to ensure submissions to regulatory agencies, collaborators, internal destinations, and contract research organizations (CROs) are aligned
- Proactively investigate potential issues or noncompliance and raise trends and critical issues to management
- Lead investigations of non-compliance issues and identify root cause for late ICSR submissions
- Address and implement appropriate corrective actions related to ICSR submission activities
- Assist in the management and oversight of ICSR transmissions between the PV Intake Tool and Argus database and from collaborators to Argus database
- Proactively identify and lead continuous improvement/quality system initiatives through evaluation, development, and roll-out of process efficiencies applicable to all deliverables
- Author new and update existing SOPs and working instructions, and conduct related training
- Minimum of Bachelor's Degree, Master's Degree preferred, in one of the life sciences or clinical research and/or licensed healthcare professional required
- Previous experience in drug safety and safety reporting in pharmaceutical/biotech industry is required with minimum of 8 years
- Able to independently and expertly identify, analyze, and problem-solve complex issues and trends
- Strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes
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Global Patient Safety Lead
7 days ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Title:Global Patient Safety LeadDescription:The Global Patient Safety Lead role is the primary point of contact for all safety-related issues within a given therapeutic area. This role serves as the first point of contact for all safety-related issues, collaborating with cross-functional teams and external stakeholders to deliver the safety strategy....
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Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team. As a key member of our Global Patient Safety team, you will play a critical role in ensuring the safety of our patients and products.Key ResponsibilitiesDevelop and implement safety strategies for molecules in clinical development and post-marketing...
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Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team. As a key member of our Global Patient Safety team, you will play a critical role in ensuring the safety of our patients and products.Key ResponsibilitiesDevelop and implement safety strategies for molecules in clinical development and post-marketing...
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Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeSenior Manager, Global Patient Safety ScientistThe Senior Manager of Global Patient Safety will play a pivotal role in shaping safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong scientific background in safety data aggregation, review, and analysis to...
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Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeSenior Manager, Global Patient Safety ScientistThe Senior Manager of Global Patient Safety will play a pivotal role in shaping safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong scientific background in safety data aggregation, review, and analysis to...
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Senior Manager of Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Senior Manager, Global Patient Safety ScientistWe are seeking a highly skilled Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.Key Responsibilities:Perform signal evaluation for identified signals and...
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Senior Manager of Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Senior Manager, Global Patient Safety ScientistWe are seeking a highly skilled Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.Key Responsibilities:Perform signal evaluation for identified signals and...
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Senior Manager of Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Senior Manager, Global Patient Safety ScientistWe are seeking a highly skilled Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.Key Responsibilities:Perform signal evaluation for identified signals and...
-
Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team at Regeneron. As a key member of our Global Patient Safety team, you will play a critical role in ensuring the safety of our patients and products.Key ResponsibilitiesDevelop and implement safety strategies for molecules in clinical development and...
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Senior Manager of Global Patient Safety
5 days ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Senior Manager of Global Patient Safety at Regeneron will play a key role in safety strategies for molecules in clinical development and post-marketing phases.ResponsibilitiesComplete signal detection activities in line with approved safety surveillance planPerform signal evaluation for any identified signals and author safety evaluation...
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Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Senior Manager, Global Patient Safety ScientistThe Senior Manager of Global Patient Safety will play a pivotal role in shaping safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong scientific background in safety data aggregation, review, and...
-
Senior Manager, Global Patient Safety Expert
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Title: Senior Manager, Global Patient Safety ScientistThe Senior Manager of Global Patient Safety will play a pivotal role in shaping safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong scientific background in safety data aggregation, review, and...
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Director of Global Patient Safety
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Director of Global Patient Safety will serve as the first point of contact for all safety-related issues for assigned compounds within a given therapeutic area. This role requires the ability to work with and influence colleagues in a matrix environment, including senior management. The successful candidate will lead the safety strategy and...
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Director of Global Patient Safety
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly experienced and skilled Director of Global Patient Safety to join our team at Regeneron. As a key member of our organization, you will be responsible for leading our global patient safety efforts and ensuring the highest standards of safety and compliance across all our operations.Key ResponsibilitiesDevelop and implement...
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Global Patient Safety Lead
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryThe Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong understanding of pharmacovigilance activities and the ability to apply relevant FDA, EU, and ICH guidelines.Key...
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Uxbridge, United Kingdom Pharmiweb Full timeJob Title: Senior Director of Global Patient Safety OperationsAt Pharmiweb, we are seeking a highly skilled Senior Director of Global Patient Safety Operations to join our team. As a key member of our Global Patient Safety organization, you will play a pivotal role in ensuring the efficient processing of pharmacovigilance operations, meeting regulatory...
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Senior Manager, Global Patient Safety Lead
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly experienced Senior Manager, Global Patient Safety to lead our Intake and ICSR submission processes. This role will be responsible for ensuring compliance with global regulations and contractual obligations.Key ResponsibilitiesLead the Intake process for adverse event data and ICSR submissionsDevelop and implement processes...
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Senior Lead in Global Patient Safety
1 week ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Description:Regeneron is recruiting a highly skilled professional to fill the role of Senior Lead in Global Patient Safety. This pivotal position is part of Regeneron's Global Patient Safety organization, specifically in the Case Evaluation & Reporting area. We seek an individual who will coordinate pharmacovigilance operations, ensuring efficient...
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Senior Manager, Global Patient Safety Expert
1 month ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team at Regeneron. This role will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area.Key ResponsibilitiesComplete signal detection activities in line with...
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Senior Manager, Global Patient Safety Expert
1 month ago
Uxbridge, United Kingdom Regeneron Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Patient Safety Scientist to join our team at Regeneron. This role will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area.Key ResponsibilitiesComplete signal detection activities in line with...