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And minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility.
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Essential Duties And Responsibilities:Oversight and review of drug safety operations practices. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions.
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The candidate must have extensive knowledge and practical experience in analyzing and characterizing Biological Drug Products (proteins, polysaccharide conjugates, vaccines) using a number of techniques, including HPLC, CE, spectrophotometric techniques, light scattering and particle sizing techniques.
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Oversight and review of drug safety operations practices. This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines. Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Experience in developing and analyzing drug delivery systems, such as polymeric and lipid nanoparticles is a plus. The candidate will be responsible for formulation and process development activities of oligonucleotide drug product programs to support Biogen’s growing pipeline.
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The incumbent should provide the expertise in characterization of drug product formulation using HPLC, GC, DSC, TGA, XRPD, dissolution apparatus, particle size analyzer, Karl Fischer titrator. Our integrated solutions offer a unique set of services for new drug candidates from drug discovery to drug product development for preclinical and clinical studies.
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We are seeking a highly motivated Senior Research Associate/Scientist to join our Drug Discovery team. The successful candidate will bring strong knowledge and bench experience in protein expression, purification, and characterization within the context of biologics drug discovery.
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Drug-Free Workplace: The Defense Logistics Agency (DLA) has established a Drug-Free Federal Workplace Policy. ADVISORY: By using cannabidiol (CBD) products you are risking a positive drug test result for marijuana.
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Under general direction and reporting to the Director of Wellness Services, the Alcohol and Drug (AOD) Prevention and Recovery Specialist provides individual substance use support for students.
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Job Title: Senior Drug Safety Specialist. · Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Maintains DHEC Regulations for Drug Court. Understanding of judicial rules and regulations governing the Drug Court program. Extensive knowledge of DHEC regulations governing alcohol and drug outpatient treatment programs.
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Loyal Source Government Services is seeking a part time Weekend Drug Testing Observation Coordinator for a part time opportunity to work with the Air National Guard based in Terre Haute, IN. JOB SUMMARY:The primary purpose of this position is to provide urinalysis specimen observation for the Drug Demand Reduction Program (DDRP.
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The Drug Court Coordinator is responsible for overseeing the drug court budget and resources, grant writing, maintaining individual files on participants, compiling statistical data and guiding or participating in the program evaluation, contract management, preparation and management of drug court dockets, and soliciting community support through education and other linkages in an effort to enhance services available to the participant.
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Loyal Source Government Services is seeking a Weekend Drug Testing Observation Coordinator to work with the Air National Guard based in Des Moines, IA. For more information please contact Jenna Browning at jbrowning@loyalsource.com.
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