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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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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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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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Senior Drug Safety Specialist, Pharmacovigilance Records & Compliance 2022831 Location: Cambridge, MA (Onsite) Science: Small Molecule Therapeutic Area: Oncology Job Overview: In this role, you will be a key contributor to drug safety activities, focusing on records management and compliance to ensure tasks align with SOPs, policies, standards, and regulations.
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The Drug Safety & Pharmacovigilance Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned products throughout lifecycle.
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Minimum of Bachelors degree in Life Sciences, Healthcare, or relevant field/ equivalent qualification with 8 years of experience working in Drug Safety/Pharmacovigilance Operations. Prior experience in Pre-marketing Drug Safety/Pharmacovigilance Operations.
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MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics. Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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PSM Manager will organize and maintain the Process Safety Management program for Echo Lake Foods ammonia refrigeration systems, equipment and personnel. His/her duty is to ensure the facilities are in compliance with all federal/state/local regulations involving process safety and risk management associated with the anhydrous ammonia refrigeration systems.
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Phoenix Job Corps has an exciting opportunity for you as a Safety Officer. Policy Interpretation: Interpret and evaluate Phoenix Job Corps' safety policies and procedures, bringing them to life through practical implementation and proactive measures.
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The Branch Safety Manager will have a direct line of responsibility to the Regional Safety Director. When the Branch Safety Manager is performing job safety observations (JSO) or performing audits, he/ she reports and helps resolve all safety infractions and deficiencies to the immediate supervisor responsible for deficiency to branch and qualified solution.
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The Branch Safety Manager is responsible for ensuring OSHA, MSHA, DOT, EPA and State DEQ safety compliance requirements for his/ her assigned location's of responsibility. Helps ensure the timely completion and reporting of quarterly hose testing to the branch and corporate safety offices.
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The Branch Safety Manager will interface with corporate, regional, and branch management to ensure all safety and training issues are being properly communicated and within State and Federal compliance standards.
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Construction Health & Safety Technician (CHST) or Safety Trained Supervisor (STS) required. This Safety manager position is located in South Florida at a designated construction site and will report to the Director of Environmental Health and Safety.
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Experience in developing drug safety data management standards (CDISC, SDTM, ADAM) Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design and program reports based on the data reporting requirement in accordance with SOPs, client requirements, and regulatory guidelines.
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Oversee the operation of drug substance manufacturing at our Contract Manufacturing Partners, ensuring compliance with all regulatory, safety, and quality standards. Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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Title: drug safety Company: Pharmacists Association
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