- 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
- Hired by Matrix (Stamford, CT)
- … Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) Drug safety, pharmacovigilance and/or risk management ... Analyze requirements specified by FDA pertaining to REMS and other patient safety/ risk management programs. Document requirement specifications for the REMS… 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
- 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
- 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
- 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
- Randstad US (Philadelphia, PA)
- …global regulatory affairs and/or pharmacovigilance activities, for example, risk evaluation and management strategies, FDA interactions, submissions,adverse ... appropriate, is in line with operational plan. + Leads risk management activities - ensuring execution of...environment + Further degree (MBA/PhD) a plus + Project Management Professional (PMP) preferred skills: Pharmacovigilance , MS-WORD,… 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
- Merck (Rahway, NJ)
- …standard quality. Ensuring vendors are planning and managing timelines and employing risk management techniques across all programs. Responsible to have ... **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare...Technology (IRT) systems & Clinical Outcome Assessments (COA Program Manager oversees the successful execution of the IRT &… more
- Regeneron Pharmaceuticals (Armonk, NY)
- 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
- 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
- Randstad US (Philadelphia, PA)
- …+ Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management . + Excellent medical ... PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (eg, signal evaluation… 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
- 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
