- Unknown (Bothell, WA)
- …company goals. This role involves building and leading a team of drug safety professionals, overseeing safety data collection and reporting from clinical ... Vice President, Pharmacovigilance & Drug Safety About the Company Innovative...of global pharmacovigilance regulations, a proven track record in safety data management, and the ability to… more
- Centra Health, Inc (Lynchburg, VA)
- …to assessing patient needs, considering age and disease specific characteristics into drug therapy and adjust care according to patient response. They provide ... in their practice area. - Consults with medical staff to design custom drug regimens based on specific patient parameters including weight fluid status renal… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: This position supports statistical programming activities for late-stage drug /vaccine clinical development projects. This may include leadership of ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety , will lead the development and implementation of integrated project/product risk ... the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and… more
- Merck & Co. (South San Francisco, CA)
- …peptide experience.DPS is a multi-disciplinary research group that provides drug delivery, solid state crystal form characterization, pre-formulation and formulation ... molecule and biologics developability assessments at the development and drug discovery interface. Our team is responsible for the...yourself with minimal supervision. You will generate these key data sets and convey their meaning to the teams… more
- Merck & Co. (Boston, MA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... trialsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical… more
- Insmed Incorporated (San Diego, CA)
- …clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety , and quality assurance teams, as well as overall ... and work with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific...safety to provide support and scientific review of safety data and study plansSupport corporate objectives:Development,… more
- Cipla (Fall River, MA)
- …enhancements. Support initiatives aimed at improving overall productivity through data analysis and performance reviews. Develop and maintain strong professional ... Procedures (SOPs) as well as following current Good Packaging Practices (cGMP). Participate in safety related programs and or safety teams as needed. Enforce and… more
- Unknown (Portland, OR)
- Executive Medical Director, Drug Safety About the Company Highly regarded biopharmaceutical company Industry Biotechnology Type Privately Held, Private ... The Company is seeking an Executive Medical Director for Drug Safety . The successful candidate will be...will be responsible for the assessment and interpretation of safety data from various sources, including clinical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical… more
- Unknown (San Diego, CA)
- Executive Director, Drug Safety & Pharmacovigilance About the Company Fast-growing biopharmaceutical company Industry Health, Wellness and Fitness Type Public ... Role The Company is seeking an Executive Director for Drug Safety and Pharmacovigilance. The successful candidate...and will be accountable for the medical evaluation of safety data . Candidates for this role should… more
- Merck & Co. (Rahway, NJ)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... assignedSupport end of study administrative activitiesAssist in the submission of data and reports for Quality reviewManage project inventory and supporting… more
- Merck & Co. (Rahway, NJ)
- …Communication, Communication Management, Customer-Focused, Data -Driven Decision Making, Drug Product Development, Estimation and Planning, General Safety , ... safety of others.-Knowledgeable of cGMP's, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, maintaining our facilities and assuring the integrity...Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and in ... across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and… more
- AUROBINDO (Durham, NC)
- …with relevant rules and regulations, such as current USP-NF, cGMP, safety protocols, in-house SOPs, and testing procedures.QUA ResponsibilitiesLeading a quality ... Operations: Oversee the quality control department's day-to-day operations.Responsible for Data Integrity compliance and laboratory GLP/cGMP/GxP complianceEnsuring the accuracy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, maintaining our facilities and assuring the integrity...contracting, distribution channels, and products (understanding of therapeutic areas, drug administration) Novo Nordisk is currently in the process… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... life-saving therapeutics to the patients who need them.Essential ResponsibilitiesCompile/process data (make power export)Prepare summary tablesPeer review raw dataOrder… more
- Merck & Co. (Boston, MA)
- …cell-line agnostic morphological embeddings and classifiers Comply with our company's safety and data retention policies, including documenting experimental ... Job DescriptionDevelopment of a Cell-Line Agnostic Cell Painting Platform for Drug Discovery.Be a part of the legacy: Postdoctoral Research Fellow ProgramOur… more
