- Daiichi Sankyo, Inc. (Bernards, NJ)
- …through meeting management , development plan/timeline management , scope management , stakeholder management , risk /issue management , finance ... management required- Strong knowledge of patient safety and pharmacovigilance highly preferred Licenses and Certifications- Certified Project Management … more
- Sumitomo Pharma (Columbus, OH)
- …a dynamic, highly motivated, and experienced individual for the position of ** Manager , Pharmacovigilance Scientist.** The Manager , Pharmacovigilance ... to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities**… more
- University of Colorado (Aurora, CO)
- IND/IDE Office Program Manager - 34555 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Clinical Research and ... Operations Services** **Job Title: IND/IDE Office Program Manager ** **Position #: 797456 - Requisition #: 34555** **Job Summary:** Key Responsibilities: **Program … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …leading pharmacovigilance projects and initiatives. + Experience with pharmacovigilance databases and safety management systems. + Hands-on experience ... on real-world evidence, and creating hope for all facing illness. As a Manager , Drug Safety Data, you will be responsible for managing and analyzing safety… 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)
- …Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) + Provide high... assessments + Promote and Advance the Field of Pharmacovigilance + Any other tasks assigned by manager… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …through meeting management , development plan/timeline management , scope management , stakeholder management , risk /issue management , finance ... and immune disorders. **Summary** This position is responsible for supporting project management and operational activities as part of the Project Management … 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …safety aggregate reports as needed. The Manager , Drug performs medical analyses for risk characterization to develop Risk Management Plans (RMPs). The ... Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will perform signal management ...Global Safety Team (GST) Chair to provide strategic product risk management throughout product lifecycle for assigned… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and ... with study teams, relevant functions and other GDQ functions to lead risk -based quality management activities on all Regeneron-sponsored clinical trials,… 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
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality function and is a bridge between ... Device Combination Products. The role will enable efficient communication to management with decision-making responsibilities related to the quality of design… 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
- Amgen (Washington, DC)
- …support across the life cycle of Amgen products, supports the development of risk management plans, and completes pharmacovigilance studies + Conducts ... other innovative, driven professionals in this meaningful role. **Observational Research Manager -** **CfOR (Obesity)** **Job Description** **Do you want an exciting… more
- Boehringer Ingelheim (Ridgefield, CT)
- …innovations to life-changing medicines for patients. It includes Strategic Consulting, Pharmacovigilance , Call Centers and BPO Services. The role will be responsible ... etc. ). + Identifies, evaluates and classifies sourcing risks and devises risk mitigation measures. + Maximizes usage of Master Services Agreements (MSAs) or… more
- System One (Basking Ridge, NJ)
- …MD degree is acceptable) Client's JD: Position supports safety monitoring and risk management activities for products in development. This position will ... Up to $100/hr dependent on experience. Notes from Hiring manager : + Rare disease is a plus + international...+ international MD is okay + 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from… more
- ThermoFisher Scientific (Austin, TX)
- …experience related to FDA/Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation/ management , regulatory reporting ... Health Authority Inspection. Additionally, you will coordinate and support inspection management tasks for global health authority inspections of PPD. Key… more
- Boehringer Ingelheim (Fulton, MO)
- …certain studies conducted in the facility (GLP - Test Facility Management ). Together with scientific directors, oversees assigned vaccine and pharmaceutical ... Innovation studies with focus on site effective resource management and planning for advancing projects according to approved priorities. Supports the development of… more
- AbbVie (North Chicago, IL)
- …including but not limited to, medical safety assessments, regulatory responses and risk management plans + Review Immunology platform protocols and represent ... in platform programs + Interact with safety governance for combination safety management strategy (SOPs, aggregate reports, SSL, etc.) + Contribute to Health… more
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