- 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
- 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
- Sumitomo Pharma (Boston, MA)
- …including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned pharmaceutical / biological / drug device combined products, accountable for the safety strategy and major ... and develop risk management plans including risk minimization measures to address specific safety concerns related to the drug in development or a product… more
- Merck (Boston, MA)
- …for interacting with health agencies (eg FDA); understand key elements in pharmacovigilance , drug safety monitoring, signal detection and processing ... of study findings; (b) **Global Regulatory Affairs and Clinical Safety :** Focus on late-stage and lifecycle drug ...Clinical Safety :** Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures… more
- Sumitomo Pharma (Boston, MA)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… 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 ... **Job Title:** Global Safety Officer **Location:** Morristown, NJ Cambridge, MA **About...pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution… more
- Takeda Pharmaceuticals (Boston, MA)
- …and AI/Machine Learning to support the department's data needs; Solve business problems in drug safety which provide an increased understanding of such tools and ... (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop...related experience. Prior experience must include: Utilize knowledge of drug safety systems, including the underlying data… 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