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The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective. EXPERIENCE/THE IDEAL FOR SUCCESSFUL ENTRY INTO JOB:Cultivates and demonstrates an in-depth knowledge of Drug Development business capabilities focused on Patient Safety.
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We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Extensive drug safety/pharmacovigilance experience within the pharmaceutical/biotechnology industry that includes development of innovative drugs, preferably in immuno-oncology/ inflammation therapeutic area(s.
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Familiarity with related fields: pharmacology, toxicology, and drug development. Partners with data scientists, toxicologists, pharmacologists, and CRO partners to develop optimal strategies to address specific toxicology issues and rapidly prioritize the safest compounds for progression through development.
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Understanding of student development, risk prevention and event planning concepts, and health and safety issues in the fraternity and sorority community. The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters.
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Serves as a Subject Matter Expert and provides guidance to County employees on matters of Department of Transportation (DOT), Federal Motor Carrier Safety Administration (FMCSA), Code of Maryland Regulations (COMAR), and Howard County policy for drug and alcohol testing and Entry Level Driver Training requirements as requested.
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Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
$99,900 - $166,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.
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We include providing EHS services to various sectors to include construction management, fueling systems recurring maintenance and minor repairs, transportation, Energy, renewable fuels, government (local, state, and federal), Department of Defense, private development, higher education, and water resources and restoration.
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15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu of a PharmD / PhD / MD degree of industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
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Has managed drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls/withdrawals, and safety-related label changes.
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Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements. Develops, reviews and updates drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form, PADER template etc.
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Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute to the development of risk management and pharmacovigilance plans.
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drug development jobs Title: safety in Crossville, Tennessee
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