- Parexel (Trenton, NJ)
- …considered. + Good knowledge/understanding of medical terminology + Relevant experience in pharmacovigilance / Drug Safety / Clinical Practice **Education:** + ... labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness… more
- Taiho Oncology (Princeton, NJ)
- …a pharmaceutical, biotech or related environment. + Minimum 7 years' experience in pharmacovigilance , drug safety , or regulatory labeling within the ... a transformative journey with Taiho Oncology as a Senior Manager , Global Labeling and PV Operations. At the forefront...you'll have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and… more
- Sumitomo Pharma (Trenton, NJ)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Partners. + Four (4) years of experience ensuring compliance with safety agreements related to pharmacovigilance process. **Compensation** **:** $179,150 ... **Position Title:** **Senior Manager , Case Management Operations - Intake (Princeton, NJ)**...data capture tools. + Assign appropriate product/project coverage through safety personnel assignments Monitor intake and workflow for compliance… more
- System One (East Windsor, NJ)
- …Sterile Injectable Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be responsible ... establishing the internal QA review system to supervise the Pharmacovigilance Group (PVG) function, which is handled by a...a QA system to notify the US Food and Drug Administration (FDA) of illegitimate products, as and when… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research &… more
- Sanofi Group (Morristown, NJ)
- …for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities eg: leading or contributing to key study documents and ... opportunities in the therapeutic area. + Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist,… more
- Bristol Myers Squibb (Princeton, NJ)
- …(SBRA) Lead will report into the Structured Benefit-Risk Assessment Head within Safety Evidence and Sciences and will be accountable to lead structured benefit-risk ... collaboration with relevant departments across the organization, including medical safety assessment, clinical development, global regulatory, epidemiology and others.… more
- Sanofi Group (Morristown, NJ)
- …all function stakeholders (eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, ... under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety -related issues, ... of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager )** As an integral member of the ecosystem team for Otsuka's new… more
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