• Merck & Co. (North Wales, PA)
    …of- pharmacovigilance and risk management plans with direction/guidance from the Clinical Safety and Risk Management (CSRM) team.Assists the CSRM ... efforts to product teams regarding safety evaluation and risk management throughout clinical , submission and post-marketing phasesWith minimal guidance,… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …Executive Director for CSRM will be responsible for overall clinical risk management and safety surveillance of assigned investigational ... Job DescriptionUnder the general direction of the Vice President, Chief Safety Officer, and Clinical Safety and Risk Management (CSRM) TA Lead, the… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and immune disorders.Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …for the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support ... design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive… more
    HireLifeScience (03/27/24)
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  • Novo Nordisk Inc. (Miami, FL)
    …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics… more
    HireLifeScience (03/06/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    safety surveillance and risk management , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, ... centered around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product ...topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …ensures continuity of site relationships through all-phases of the trial.-Performs clinical study site management /monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, ... Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.Reports and Submissions: May… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as well as management of adverse events based upon approved Safety Management Team (SMT) materials.Supports overall program safety reporting ... of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the... sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial… more
    HireLifeScience (03/07/24)
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  • Merck & Co. (Rahway, NJ)
    …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer ... will serve as a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility. --This role will support formulation and process development, scale-up… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …Director, Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day operations of the clinical ... screening of literature on company products to support pharmacovigilance and drug safety and for use in the Product Literature Database.-Responsibilities but are not… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …from other groups/departments.- Warehouse-specific Responsibilities: Perform incoming material receipt, clinical site drug returns and sample management .Receive, ... Senior Packaging Technicians, work within a team environment to execute clinical packaging and labeling activities, including material, room and equipment staging,… more
    HireLifeScience (03/15/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products throughout ... the benefit- risk documents for assigned products and development compounds. Develops Safety Management Plans. Directs the compilation and interpretation of … more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as ... and during post marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to require additional nonclinical … more
    HireLifeScience (03/01/24)
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  • Catalent (Harman, WV)
    …systems, including investigation/deviation management , CAPA tracking, change control, risk management , supplier quality, audits and inspections, raw ... Provides strategic direction to the QA Systems staff supporting Investigation/Deviation/ CAPA Management , Change Control, Risk Management , Quality Metric… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …team, work collaboratively to ensure that compliant environmental, health, and safety (EHS) programs are developed and implemented within operating departments at ... supervision.Primary Activities With a deep knowledge of environmental, health, and safety regulations and their applicability, supports R&D customer business areas… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position ... be programmed; an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
    HireLifeScience (03/26/24)
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  • George Washington University (Washington, DC)
    …such as sustainable cities and food systems, climate change, infectious diseases, workplace safety and risk management . The microbiome and molecular ... from Dr. Liu and collaborators to collect metagenomic/transcriptomic/proteomic/metabolomic data from clinical studies and in vitro experiments. Work closely with Dr.… more
    JobGet (03/01/24)
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