- Parexel (Boston, MA)
- …considered. + Good knowledge/understanding of medical terminology + Relevant experience in pharmacovigilance / Drug Safety / Clinical Practice **Education:** + ... labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness… more
- Sanofi Group (Cambridge, MA)
- …and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, I&I **Location:** Morristown, NJ Cambridge, MA...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sanofi Group (Cambridge, MA)
- …knowledge of product, product environment, and recent literature + Maintain expertise in drug safety and PV, and understanding of international safety ... and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of… more
- Sumitomo Pharma (Boston, MA)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional… more
- Parexel (Boston, MA)
- …Experience with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + ... feasibility assessments + Contribute medical insights to protocol design and drug development programs + Support pharmacovigilance activities including medical… more
- Sanofi Group (Cambridge, MA)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research &… more
- Pfizer (Cambridge, MA)
- …experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management + Knowledge of global safety regulations and ... guidelines, or equivalent, + Demonstrated experience in global drug safety risk management planning activities and generating RMPs + Demonstrated strength in… more
- Sanofi Group (Cambridge, MA)
- …Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (eg planning and review of narratives) ... review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams)...cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance . **About You** **Knowledge And Skills Required** : +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety , Clinical Sciences, Outcomes, Digital Health, Pharmaceutical ... clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and… more
- Sanofi Group (Cambridge, MA)
- …Scientist_ + _Location: Cambridge MA_ **About the Job** **Our Team:** _The Lunsekimig project team is part of Early Development in the Inflammation & Immunology ... Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/ project . + Contributes to the definition of the critical… more
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