- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure… more
- Parexel (Olympia, WA)
- …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
- BeOne Medicines (Emeryville, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report ... medical field or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. + MD (or internationally recognized equivalent) plus… more
- Sumitomo Pharma (Providence, RI)
- …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
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Coordinate activities with Quality (QC/QA), Manufacturing, Regulatory Affairs, Pharmacovigilance / Safety , Supply Chain, Clinical Development, Compliance, Legal, ... and help create more tomorrows. **Job Description** **Position Summary** The Manager , OOS & Expanded Access Program will lead the end-to-end Out-of-Specification… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a… 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 (Cambridge, MA)
- …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
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