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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired. Minimum of 10 years drug development/FDA/regulatory related industry experience required.
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Qualifications & Experience:MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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This role involves collaboration across various teams to generate real-world evidence for drug effectiveness and disease insights using diverse data sources such as claims and electronic health records.
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5+ years Drug Safety/Pharmacovigilance experience. Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug) 5+ years Drug Safety/Pharmacovigilance experience.
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MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Must have a Licensed Clinical Alcohol and Drug Counselor (LCADC) and Licensed chemical dependency counselor (LCDC) Oversee the development of treatment / behavior / support / safety plans, as needed.
$75,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
$150ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Interfacing with key thought leaders and experts in oncology and immuno- oncology drug development. Experience: Significant clinical research and drug development expertise and leadership experience (10 years or greater) in oncology.
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The Director, Global Drug Development Project Manager, will serve as a global drug development project manager and provide professional services to global development projects and One Kyowa Kirin.
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Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines.
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Excellent knowledge and understanding of the drug development process (clinical trials, efficacy endpoints, biomarker testing) 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.
$142,500 - $237,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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. Bristol Myers Squibb encompasses a broad range of disciplines to enable a robust pipeline of drug candidates aimed at serious diseases.
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NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing.
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drug job Title: director safety in Rocky Hill, NJ
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