- Novo Nordisk Inc. (Plainsboro, NJ)
- …management for vendors handling safety information Leadership: Provides strong people management of the Patient Safety leadership team across NNI, ... Position As North America responsible person, the head of Patient Safety will act as the ...reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements.… more
- Genmab (Plainsboro, NJ)
- …all major pre- and post-marketing safety related deliverables including signal, benefit- risk evaluation, and risk management activities. This individual ... literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required ... the actual product Responsible for all areas related to patient safety in clinical trials Act as...ensures coordination with other project deliverables Is responsible for Safety Input to all activities for Risk … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required ... include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global...the actual product Responsible for all areas related to patient safety in clinical trials Act as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The one thing that keeps us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients around the world. As their needs ... including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works...(SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provide updates, ensure alignment and monitors vendor activities Leverages knowledge of risk management standards for current processes, projects, and systems ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management ... collaboration with clinical development staff.Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and completeness of all business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and completeness of all business… more
- Merck & Co. (Durham, NC)
- …manufacturing division Quality Manual or with potential for impact on product quality, patient safety or data integrity. Work closely with stakeholders and SME's ... objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work. Provide the independent quality… more
