- 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
- Astrix Technology (Red Bank, NJ)
- …with a focus on pharmacovigilance or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with ... SOPs, and quality standards. + Collaborate with cross-functional teams including drug safety , regulatory affairs, clinical development, and biostatistics. +… more
- Parexel (Trenton, NJ)
- …Experience with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + ... feasibility assessments + Contribute medical insights to protocol design and drug development programs + Support pharmacovigilance activities including medical… more
- Taiho Oncology (Princeton, NJ)
- …a pharmaceutical, biotech or related environment. + Minimum 7 years' experience in pharmacovigilance , drug safety , or regulatory labeling within the ... Global Labeling and PV Operations. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment...you'll have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and… more
- Sumitomo Pharma (Trenton, NJ)
- …including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in ... **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's… more
- Merck (Rahway, NJ)
- …for interacting with health agencies (eg FDA); understand key elements in pharmacovigilance , drug safety monitoring, signal detection and processing ... of study findings; (b) **Global Regulatory Affairs and Clinical Safety :** Focus on late-stage and lifecycle drug ...Clinical Safety :** Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities + Are responsible for the strategic execution of ... complex audits across broader R&D functions, external vendors, and critical pharmacovigilance workstreams and processes. **_**We are seeking a candidate to sit… more
- Sanofi Group (Morristown, NJ)
- …and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, I&I **Location:** Morristown, NJ Cambridge, MA...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
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