- Merck & Co. (North Wales, PA)
- …overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities.-Manage PV systems: Responsible for managing PV ... with risk -based monitoring and other industry applications used for Pharmacovigilance .Current Employees apply HERE Current Contingent Workers apply HERE US and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for… more
- 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
- Merck (West Point, PA)
- …overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities. + Manage PV systems: Responsible for managing ... risk -based monitoring and other industry applications used for Pharmacovigilance . Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers… more
- BeiGene (San Mateo, CA)
- …Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans. + Supporting the activities related to the ... **_General Description:_** The Senior Manager , GCP Inspection Management is responsible...metrics (ie; protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends… more
- United Therapeutics (Columbus, OH)
- …and decisions to support the overall global safety surveillance program and proper management of benefit/ risk of UTC products. This position can be remote ... diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in management and oversight of… 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
- BeiGene (San Mateo, CA)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related...(PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). + Lead and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …critical contributions into and reviews aggregate safety reports, prepares or approves Risk Management Plans (RMPs), leads the Gilead Structured Assessment of ... working with aggregate safety reports with oncology experience preferred. + Experience developing risk management plans and risk minimization with oncology… 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 (North Chicago, IL)
- …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
- Astellas Pharma (Northbrook, IL)
- …PV requirements, as applicable. + Support the implementation of local activities concerning risk management and risk minimization, as applicable. + Ensure ... PV Affiliate Support Function colleagues on matters relating to strategy, management , and compliance that impact PV. **Essential Job Responsibilities:** **Strategy… more
- Cella Inc (North Chicago, IL)
- …suppliers to collect or correct missing details. Record results and collaborate with management to identify systemic issues and risk reduction plans. Supplier ... identify completed projects. Review project documentation for compliance with Pharmacovigilance , OEC, Finance, and Procurement standards. Follow up with researchers… more
- Sanofi Group (Cambridge, MA)
- …tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan + Is involved in the update of study ... + 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
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