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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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Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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Exemplify is seeking an experienced Senior Analytical Chemist to join our dynamic drug development team. Demonstrated experience in method development, trouble shooting, and validation (HPLC, dissolution, GC, LC-MS) in support of NCE drug product development and release.
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Support key executives within Drug Development in thought leadership initiatives designed to elevate the company's reputation in Immunology, CV and Neuroscience. Execute the communications strategy in support of clinical trial recruitment goals for select studies across Immunology, CV and Neuroscience in close collaboration with the Global Drug Operations team within Drug Development.
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Responsible for oversight of the outsourced analytical development activities associated with the development, validation, technology transfer, and line extension of drug product. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results related to drug product development in reports and certificates of analysis.
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First licensed substance use disorder treatment provider and CARF accredited program in the state of New Jersey
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Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
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Coordinate preparation of Drug Master files with CMC team at Guerbet France. Evaluates labeling of drug products per the current FDA labeling requirements. at Guerbet, you will collaborate closely with our Senior Regulatory team, engaging in critical meetings and interactions with the FDA to shape regulatory processes for both our existing and upcoming drug products.
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Chemistry is a core capability in Small Molecule & Drug Discovery with innovative scientists working in medicinal chemistry, radiochemistry, analytical chemistry, and large-scale synthesis.
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Proficiency with drug safety databases (i.e., Argus), electronic data capture (EDC) systems, Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug dictionary coding.
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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
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The Drug Safety Associate is responsible for assigned Sun Pharma Risk Evaluation and Mitigation Strategy (REMS) programs and for other Pharmacovigilance activities as detailed below. Prescription Drug Coverage.
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3-5 Years experience in Drug Safety with Similar Task. Participates and contributes to the designated product Safety Governance meetings and other routine interactions with OPDC Pharmacovigilance.
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Our client is looking to fill the role of Drug Safety Physician. Contribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Otsuka Pharmaceutical Development & Commercialization, Inc. and a CRO.
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Title: drug discovery Company: Schrdinger in Monmouth Junction, NJ
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