- Merck & Co. (Upper Gwynedd, PA)
- …and worldwide Regulatory Health Authority requirements.Experience with delivering effective CAPA management solutions.Experience with risk management tools ... and follow up of regulatory inspections.Primary Responsibilities:Operational Quality Management Develop Risk Assessment and Categorization Tools and… more
- Merck & Co. (North Wales, PA)
- …tools is required.-Basic knowledge of Site Monitoring, Study Start up, Data Management , Pharmacovigilance , Essential Document Management , and Investigator/ ... around technology.-Apply data stewardship and data governance principles in the management of the application.-Collect, assign, track, and prioritize requests from… more
- Sanofi Group (Bridgewater, NJ)
- …PV findings. + Support completion of Health Authorities and Business partners pharmacovigilance risk assessment questionnaires to facilitate risk -based PV ... **Job title:** Pharmacovigilance Audit and Inspection Readiness Manager ...clinical development activities. + 5+ years of experience in Pharmacovigilance or clinical field, preferably in quality management… more
- Kelly Services (OH)
- …+ years Pharmacovigilance experience * Extensive signal detection and safety risk management experience **Knowledge, Skills and Abilities:** * Expertise in ... **Kelly(R) Science & Clinical** is seeking a Pharmacovigilance Manager for a fulltime, contract...assigned products, development and execution of safety signal and benefit- risk management strategies and closely collaborate with… more
- ThermoFisher Scientific (Greenville, NC)
- …Affairs activities which include the specific value proposition for the client/sponsor ** Management Role:** Manager role with significantly larger management ... selection, job description preparation, professional development, goal setting, performance management , behavioral and technical coaching and mentoring, employee counseling,… more
- Takeda Pharmaceuticals (Boston, MA)
- …of exposure in preparation and submission of periodic aggregate safety reports and risk management plans. + Demonstrated experience in people management ... motivating and developing people. + Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk /benefit analysis. +… more
- BeiGene (San Mateo, CA)
- …findings. + Collaborate with cross functional compliance teams to develop integrated Quality Management Risk plans. + Lead the analysis and interpretation of key ... **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence...(ie; protocol deviation, etc.) as part of the Quality Management Risk (QMR) approach to identify gaps,… more
- BeiGene (San Mateo, CA)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... + Update Reports (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) + Lead and demonstrate ability to resource,… more
- BeiGene (Emeryville, CA)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... Safety Update Reports (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) + Provide high quality support and fulfill… more
- Amgen (Thousand Oaks, CA)
- …other innovative, driven professionals in this meaningful role. **Quality Compliance Manager , Safety & Medical Quality** **Live** **What you will do** Let's ... compliance/quality oversight bodies and participate in quality investigations and management and remediation of compliance issues relating to processes, programs,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk -based quality management ... The Regeneron GVP Quality Management Lead (QML) is a key position that...global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at… more
- Organon & Co. (Jersey City, NJ)
- …The Project Manager may also be assigned to provide program management expertise as an individual contributor to teams leading the development or life-cycle ... **The Position** We are looking for an experienced Associate Director, Project Manager to join our team. This successful candidate will provide project … more
- Merck (Columbus, OH)
- …Experience with delivering effective CAPA management solutions. + Experience with risk management tools and processes within the clinical quality framework. ... and follow up of regulatory inspections. **Primary Responsibilities:** Operational Quality Management + Develop Risk Assessment and Categorization Tools and… more
- University of Miami (Coral Gables, FL)
- …studies across all stages of clinical development. The Clinical Research Project Manager reports to the Director, Clinical Research Management Support Office. ... ensure adherence to study timeline. + Collaborates with medical research, data management , biostatistics, pharmacovigilance , and other functions to ensure data… more
- BeiGene (Emeryville, CA)
- …review of study related metrics (ie; protocol deviation, etc.) as part of the Quality Management Risk (QMR) approach to identify gaps, trends, and the need for ... **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence...in a global context. + Demonstrated experience in quality management , process management /improvement, and risk … more
- Chiesi (Cary, NC)
- …the United States. This position is also responsible for providing input to risk management activities, working in the labeling control process, including ... Ad Promo Manager , Americas Regulatory Affairs, Global Rare Diseases Date:...submission of changes to new or existing labeling. + Risk Management Responsibilities: + Provide input to… more
- AbbVie (Florham Park, NJ)
- …are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team physicians, epidemiologists, ... ranging from early to later stages of development and life cycle management , with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …in clinical study team meetings for assigned compounds + Participate in other risk management activities as appropriate for assigned compounds + We may ... The Senior Manager of Global Patient Safety (GPS) will play...PhD, or PharmD + Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech… more
- Takeda Pharmaceuticals (Boston, MA)
- …interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity. + Support ... in technologies affecting Clinical Operations, Clinical Supplies, Regulatory Affairs, Data Management , and Pharmacovigilance to support further innovation within… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent ... You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices. You… more
