- AssistRx (Maitland, FL)
- …consistent alignment with global regulatory requirements for drug safety, reporting, and risk management . This role is instrumental in establishing and ... The Manager , Pharmacovigilance - Front End Operations...regulatory authority inspections. + Conduct regular assessments of PV risk management , identify and address compliance gaps,… 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
- 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
- Takeda Pharmaceuticals (Columbus, OH)
- …and patient safety for company's products. + Represent all activities related to pharmacovigilance , clinical safety, risk management and signal detection, ... processes. You will collaborate with cross-functional teams eg, PSPV Training, PSPV Risk Management & Education, and Document Learning Excellence (DLE) to… more
- BeiGene (San Mateo, CA)
- …Quality + Clinical Operations + Pharmacovigilance + Clinical Business Operations + Risk Based Quality Management + Biometrics + Medical Monitors + Regulatory ... **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
- 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 (Armonk, NY)
- …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
- 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
- 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 (Tarrytown, NY)
- …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
- AbbVie (North Chicago, IL)
- …. Support departmental need to contribute to and develop content for sections of risk management plans, benefit risk assessments, safety, and regulatory ... in this position will provide support to the Global Epidemiology Department in Pharmacovigilance & Patient Safety. This person will contribute to the design and… more
- Sanofi Group (Bridgewater, NJ)
- …tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan + Is involved in the update of study ... clinical studies on activities pertaining to the Study Medical Manager responsibilities eg: managing or contributing to key study...to develop good practices, using a critical data-driven and risk management approach + Familiar with digital… more
- Sanofi Group (Cambridge, MA)
- …guidelines, as regard to medical data review activities, using a data-driven and risk management approach + Support to regulatory documents filing and archiving. ... + Quality focused, able to develop good practices, using a critical data-driven and risk management approach + Familiar with digital tools such as data analytics… more
- Nestle (Brisbane, CA)
- …new GxP systems to support NHSc product portfolio. + Serve as Project Manager for technology implementations, including coordination and management of external ... of biotech/pharmaceutical manufacturing systems and processes supporting drug safety, pharmacovigilance , manufacturing, engineering automation, regulatory compliance, quality management… more
- Sanofi Group (Houston, TX)
- …company, industry, legal and regulatory requirements; + Demonstrate operational understanding and risk management by ensuring excellence in execution of all ... Rare Hematology Medical Science Liaison TX, NM, AZ **Grade/Level** : L3-1 **Hiring Manager ** : Tia Nguyen **Location** : Remote, Territory includes TX, NM, AZ.… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …tools, templates, working practices within Clinical Development. Reports to Manager , Clinical Development Scientist. **Primary Responsibilities:** + Participates in ... Generation group such as with Biometry, Clinical Operations, Pharmacology, Pharmacovigilance , and HEOR. + Synthesizes literature and competitive information for… more
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