- Colgate-Palmolive (Piscataway, NJ)
- …Summary** Serve as the Lead point of contact for all Global Pharmacovigilance functions and processes for internal & external customers and stakeholders. Contribute ... key support functions in delivering vision, training and awareness of Global Pharmacovigilance to PV and all Colgate-Palmolive employees + Lead the operational… more
- Merck (Rahway, NJ)
- …Communication, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Management Process, Pharmaceutical Regulatory Compliance, ... **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case review/approval… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and ... of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/ Safety /biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …translational sciences, statistics, programming, outcomes research and epidemiology, and patient safety & pharmacovigilance ) bring their expertise to our global ... of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/ Safety /biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports; + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- United Therapeutics (Concord, NH)
- …and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety ... ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting… more