Trabajos safety director en Bridgewater, New Jersey (NJ) State

... and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review · Prepare relevant ... safety/pharmacovigilance in clinical development and post-marketing preferably in oncology · ...

As the Senior Director of Pharmacovigilance QA, you will play a pivotal role in managing quality ... Shape the Future: Be a key strategic partner in shaping the direction of drug safety and ...

He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a proactive safety strategy at the start of Phase 1. Grow and maintain connections with...

This role will have the medical safety expertise to perform obligatory safety functions with oversight from global drug safety lead. Lead the development of safety risk management plans, safety components of IND/NDA/MAA filings, annual safety reports. Ensuring safety of products through the produ...

Safety Expert – Overall: Develops safety knowledge working closely with CSPV management. Safety Expert – Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members. This position supports safety monitoring and risk management activities, provides in....

Collaborate with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate sa...

The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-mar...

Safety Expert – Overall: Develops safety knowledge working closely with CSPV management. Safety Expert – Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members. This position supports safety monitoring and risk management activities, provides ins...

The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-mar...

He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a proactive safety strategy at the start of Phase 1. Grow and maintain connections with...

He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a proactive safety strategy at the start of Phase 1. Grow and maintain connections with...

Safety Expert - Overall: Develops safety knowledge working closely with CSPV management. Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members. This position supports safety monitoring and risk management activities, provides ins...

In this role, a typical day might include:* This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage...

The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-mar...

This role might be for you if can:* Serve with direct responsibility for overseeing all aspects of GPS safety monitoring activities for assigned compounds (primarily gene therapy) to drive safety surveillance, signal management, communication of the safety profile as appropriate for the stage in ...

He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a proactive safety strategy at the start of Phase 1. Grow and maintain connections with...

Director position is directly responsible for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses ...

Reporting to the Vice President of the Diagnostics and Genomics (DGG) Quality organization within Global Quality and Regulatory Affairs (GQRA), the Director of Clinical and Safety Quality Assurance will be responsible for setting strategy for and leading the Clinical and Safety Quality Assurance ...

This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assess...

Responsibilities**+ Safety Expert - Overall: Develops safety knowledge working closely with CSPV management. Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members. Summary**This position supports safety monitoring and risk manage...

SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, p...

Join a Legacy of Innovation 110 Years and Counting!**Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technolog...

Be an active partner and core contributor of safety input to key regulatory or clinical documents including:+ Risk management plans+ Clinical Trial, EAP and IIS Protocols+ Informed Consent Forms (ICF), including Risk Language+ Safety Sections of Investigator's Brochure (IB) and IB addenda+ Safety...

Director position is directly responsible for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses ...