- The Fountain Group (Basking Ridge, NJ)
- …Fountain Group are a national staffing firm and are currently seeking a Director, Clinical Safety for a prominent Pharmaceutical client of ours. This position is ... Length of Assignment: 1 year to start with potential to extend or convert. The Director, Clinical Safety , will be a product safety lead or part of a product … more
- Eisai, Inc (Nutley, NJ)
- …related technical and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director ... is your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise in addressing technical challenges in the programming… more
- Intermedia Group, Inc. (Woodland Hills, CA)
- OPEN JOB: Clinical Patient Safety Manager LOCATION: Woodland Hills, California **Relocation Assistance Available SALARY: $95,908 to $151,840 FULL-TIME BENEFITS - ... Under the general supervision of the Director Risk Management, the Patient Safety Manager is responsible for overseeing and implementing systems and processes to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) ... clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance included regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More Years Familiarity with ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this role, the incumbent will contribute to creation and improvement of Clinical Development processes. Job Description:Execute an overarching safety program ... experience in pharmaceutical industry.At least 2 years in Patient Safety .At least 2 years of experience in Clinical... Safety .At least 2 years of experience in Clinical Development.At least 2 years of Oncology experience. Competencies:An… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good ... PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (Rahway, NJ)
- …contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & ... Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating model for regulatory activities in the… more
- Eisai, Inc (Phoenix, AZ)
- …decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project TeamsGOMA and Specialty MA Management teamsData Management/ Biostats Clinical Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ ... to marketed / commercial products whereby MA is in scope for label extension, safety only studies (PH IV studies) and/ or EAP (Expanded access, lead and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety , Data Management, Statistics). This position requires skills ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Merck & Co. (Upper Gwynedd, PA)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company… more
- Formation Bio (New York, NY)
- …role, you'll pioneer the development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Macpower Digital Assets Edge (Woodland Hills, CA)
- …the general supervision of the Director of Risk Management and as Patient Safety Manager you would be responsible for overseeing and implementing systems and ... processes to ensure the safety of patients. This includes... of patients. This includes monitoring and analyzing patient safety data, developing, and implementing improvement initiatives to prevent… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of ... clinical trial execution within a pharmaceutical or biotechnology company....and CROs on timeliness, completeness, and quality metrics.Manage the Safety Alert Reporting Departments, ensuring high-quality and timely global… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Johns Hopkins Medicine (Baltimore, MD)
- …designated, academic medical facility. Our nurses are committed to patient safety , clinical excellence, optimizing outcomes through evidenced based practice, ... Cross, or Military Training Network accepted. Experienced Registered Nurse with clinical leadership experience required. Responsibilities : This position is a… more
- Genmab (NJ)
- …in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the above ... checks of data consistenciesSupports specification and pooling of data across clinical trials within the same project.Supports in-house production of analysis… more
