Head of Patient Safety
4 weeks ago
We are seeking a highly skilled and experienced Head of Patient Safety to join our team at Novo Nordisk. As a key member of our Clinical, Medical and Regulatory (CMR) department, you will play a critical role in ensuring the safety and well-being of our patients.
Key Responsibilities- Establish and Maintain Safety Processes: Develop and implement processes, procedures, and controls to ensure compliance with internal and external regulations and guidelines.
- Regulatory Compliance: Ensure compliance with US drug and device safety reporting regulations, Health Canada regulations, ICH guidelines, and other relevant requirements.
- Leadership and Collaboration: Provide strategic vision, expertise, leadership, and direction for Patient Safety in North America Operations (NAO) and contribute to the strategic vision of CMR Strategic Operations.
- Stakeholder Engagement: Build strong relationships with cross-functional teams, regulatory authorities, and vendors to ensure alignment with safety strategy and company objectives.
- Compliance and Audits: Drive preparedness for regulatory authority inspections and internal audits, and participate as a Subject Matter Expert (SME) and mentor colleagues/direct reports.
- Education: Bachelor's degree in health sciences or a relevant field; advanced degree preferred.
- Experience: Minimum 10 years of relevant experience in drug safety/pharmacovigilance or related fields, with at least 6 years of people management experience.
- Skills: In-depth knowledge of North America (US, CA), EU drug safety regulations, CIOMS, and ICH guidelines; proven track record of strategic decision-making and leadership skills.
We are a global healthcare company with a commitment to creating a better world for people with diabetes and other serious chronic conditions. We are dedicated to improving the lives of millions of people worldwide and are seeking talented individuals to join our team.
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Head of Patient Safety
1 week ago
Plainsboro, New Jersey, United States Novo Nordisk Pharma Full timeAbout the RoleThe Head of Patient Safety will be responsible for establishing and maintaining processes, procedures, and controls to ensure compliance with all relevant internal and external requirements and regulations relating to technical complaints, adverse events, and other safety information in the US and Canada.Key ResponsibilitiesCompliance with US...
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Patient Safety Training Specialist
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a dynamic and collaborative group that plays a crucial role in the organization's success. Our team is responsible for developing and implementing regulatory strategies, providing medical education, and collecting data to support efficacy and new product development....
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Patient Safety Training Specialist
5 days ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a dynamic and collaborative group within the organization.As a key member of the CMR team, you will be responsible for coordinating and overseeing Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance, as well as Safety training conducted...
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Patient Safety Specialist
4 weeks ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a highly skilled Patient Safety Specialist to join our team at Novo Nordisk. As a key member of our Clinical, Medical and Regulatory (CMR) department, you will play a critical role in ensuring the safety and efficacy of our products.Key ResponsibilitiesProcess and analyze adverse event reports and technical complaints related to...
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Patient Safety Training Specialist
1 month ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a highly skilled Patient Safety Training Specialist to join our Clinical, Medical and Regulatory (CMR) department at Novo Nordisk. As a key member of our team, you will play a critical role in ensuring the delivery of high-quality patient safety training programs to our employees.Key ResponsibilitiesDevelop and maintain...
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Patient Safety Training Specialist
4 weeks ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Patient Safety Training Specialist to join our team at Novo Nordisk. As a key member of our Clinical, Medical and Regulatory (CMR) department, you will play a critical role in ensuring the safety and well-being of our patients.Key ResponsibilitiesCoordinate and oversee patient safety training programs for...
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Global Safety Surveillance Director
1 week ago
Plainsboro, New Jersey, United States Novo Nordisk Pharma Full timeAbout the RoleWe are seeking a highly skilled and experienced Global Safety Surveillance Director to join our team at Novo Nordisk Pharma. As a key member of our Research & Development organization, you will be responsible for leading the safety surveillance sub-function within the U.S. East Coast Development Hub.Key ResponsibilitiesDevelop and implement...
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Associate Director, Global Drug Safety
3 weeks ago
Plainsboro, New Jersey, United States ZipRecruiter Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safety of our products throughout the clinical trial and post-marketing environments.Key ResponsibilitiesPerform safety...
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Associate Director, Global Drug Safety
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking an experienced Associate Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safe and effective development of our products.Key ResponsibilitiesPerform safety reviews of adverse event...
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Associate Director, Global Drug Safety
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob SummaryGenmab is seeking an experienced Associate Director to join our Drug Safety and Pharmacovigilance team. As a key member of our global safety team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking an experienced Associate Director of Global Safety and Pharmacovigilance to join our team. As a key member of our Drug Safety and Pharmacovigilance (GDS&PV) team, you will play a critical role in ensuring the safety of our products throughout their lifecycle.Key ResponsibilitiesLead Safety-Related Activities: You will lead all...
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Associate Director, Global Drug Safety Expert
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Global Drug Safety team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key ResponsibilitiesLead...
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Associate Director, Global Drug Safety Expert
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety and Pharmacovigilance team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.Key...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading our global safety strategy and ensuring the overall safety profile of our assigned products throughout their lifecycle.Key...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team in Princeton. As a key member of our team, you will be responsible for ensuring the safety of our products and collaborating with cross-functional teams to drive business growth.Key ResponsibilitiesPerform safety reviews of Adverse Event...
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Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team in Princeton. As a key member of our team, you will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical trials to post-marketing surveillance.Key ResponsibilitiesPerform safety reviews of...
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Associate Director, Global Drug Safety Expert
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety & Pharmacovigilance team at Genmab. As a key member of our global safety strategy team, you will be responsible for ensuring the safe development and marketing of our innovative antibody products.Key ResponsibilitiesLead pre- and post-marketing safety-related activities,...
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Associate Director, Global Drug Safety Expert
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Drug Safety & Pharmacovigilance team at Genmab. As a key member of our global safety strategy, you will contribute to the development and implementation of safety protocols for our investigational products.Key ResponsibilitiesLead pre- and post-marketing safety-related activities,...
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Associate Director, Global Drug Safety Expert
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeJob SummaryGenmab is seeking an experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team in Princeton, NJ. As a key member of our team, you will be responsible for ensuring the safe and effective development of our innovative cancer treatments.Key ResponsibilitiesPerform safety reviews of adverse event reports for Genmab...
