- Takeda Pharmaceuticals (Boston, MA)
- …and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management). + ... that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder… more
- Merck (Rahway, NJ)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug... safety and efficacy as well as new drug applications, clinical study reports, or publication; + Participation… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory Affairs, ... ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... and up to 2 studies in late development) + Seamless transition of drug candidates from research to early clinical development + Effective integration of in-licensed… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …including, Non-Clinical Quality, Product Development Quality, Clinical Quality, Pharmacovigilance Quality, Quality Risk Management, and Innovative Capabilities. We ... manufacture, testing and distribution of clinical supplies (investigational products) including drug substance and drug product batch disposition, support… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements....of the consumer products industry. + Experience with OTC drug regulations for FDA, Health Canada, and TGA. Medical… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the Fellow will: + Act as a company liaison with the US Food and Drug Administration. + Provide analysis, advice and guidance on US regulatory strategies. + Research ... area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. **Additional Duties &… 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