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Our team is changing, and we are building a global team passionate about patient safety in the drug development process. We are an inclusive culture that champions diversity and collaboration and we are committed to lifelong learning, growth, and development.
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Job DescriptionGeneral Summary:The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development.
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Oarticipate in development of managementís collective bargaining goals/proposals and attend collective bargaining sessions as a representative of BPHC.Represent management in grievance and arbitration process, including but not limited to hearing and adjusting grievances, and attending grievance and arbitration hearings.
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Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting. Global Safety Officer, Medical Director, Pharmacovigilance Full-time.
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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.
$239,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs from IND/CTA submission through various clinical development phases. As a study monitor, direct and oversee nonclinical toxicology studies including but not limited to genetic toxicology, safety pharmacology, general toxicology, and development and reproductive toxicology studies supporting nonclinical and clinical development programs.
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The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development.
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Do you have 10+ years of experience in drug development and in drug safety/pharmacovigilance? If you are a strong problem-solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, and enjoy cross-functional partnerships, this is the role for you.
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Lead development (e.g., advise data package, oversee authoring, review, and approval) of Safety/PV regulatory documents (e.g., DSUR) and strategy per global regulations. Participate in the development and implementation of safety policies and procedures.
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Partner with the PCS Therapeutic Area Head for alignment with PCS Therapeutic Area Strategy Teams, PCS line functions and NIBR/Novartis Development project/program teams in managing the preparation and presentation of nonclinical safety data in internal and external documents (e.g. Investigator’s Brochure, IND, CTD, IMPD, Health Authority briefing books) and in negotiation with Health Authorities.
$226,800 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Director Health, Safety & Environment is responsible for the Corporate Safety program in compliance with all federal, municipal, and company health, safety environmental policies, and regulations company wide.
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This includes contributing to the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating cross functional Safety Review Team (SRT) meetings, ensuring the completion of signal detection activities, and directing appropriate resource to all clinical development and product registration activities.
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Help preclinical project teams navigate compound safety risks through various stages of drug discovery and development, including development candidate (DC) nomination, by implementing a blend of computational, in-vitro, and in-vivo toxicology capabilities.
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The Senior Medical Director, Patient Safety will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization.
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