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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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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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The Drug Authorization Specialist, with direct supervision of the Prior Authorization Supervisor, is responsible for managing all work related to drug authorizations for all injectable drug treatment plans ordered by Dana Farber Cancer Institute providers using knowledge of payer coverage policies and applies appropriate payer guidelines to all aspects of drug prior authorization work.
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Interact with and / or supervise Drug Safety / Pharmacovigilance CROs. Senior Director, Drug Safety & Pharmacovigilance. This role allows the incumbent to build the in-house drug safety function in a fast-growing biotech and have the pharmacovigilance responsibility across the proprietary Probody portfolio.
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Albertsons Companies is a leading food and drug retailer in the United States. Our sales and store support teams, also known as clerks in the grocery world, play an important part in ensuring our stores are clean, organized, and shoppable so that our customers can find exactly what they need to keep their families healthy and fed.
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As a key member of their research and development team, you will leverage your expertise in computational chemistry and data analysis to support drug discovery efforts and advance their pipeline of therapeutic candidates.
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The responsibilities, duties, and skills of personnel may vary within store and/or from store to store and the official job description will be provided during the application process.
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Albertsons Companies is working to become the favorite food and drug retailer in every market it serves. Supervises store employees in the presences or absences of Store Manager.
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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. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions.
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This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. Develop and/or update SOPs, processes and practices for SAE and other safety data collection in accordance with drug safety and pharmacovigilance regulations, ICH standards and guidelines as appropriate to ensure timely and compliance submissions to worldwide regulatory agencies.
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Assistant Professor - Drug Delivery (Faculty) Job Title Assistant Professor - Drug Delivery (Faculty) syr.edu) is seeking applicants for a tenure-track position at the rank of Assistant Professor in the field of Drug Delivery.
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The Biologics group is responsible for various functions criticalfor drug development such as: antibody discovery, molecular biology, cell line engineering,protein engineering, biophysical analytics, and functional cell assays.
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Oversee Drug Safety Study Team Leads activities including review of study protocols, case report forms, Investigator Brochures and participation on IND Annual Reports in support of the Drug Safety Physician.
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Liaise externally with Drug Safety vendor and business partners on case management issues, processes and timelines to meet global regulatory requirements for SAE reporting and other data exchange obligations.
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drug store jobs Title: assistant store Company: Things Remembered
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