- 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
- AbbVie (North Chicago, IL)
- …and the review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical ... teams and internal stakeholders. + Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the… more
- Takeda Pharmaceuticals (Boston, MA)
- …quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance ) bring their expertise to our ... functions **Core Skill and Qualification Elements:** + Advanced knowledge of drug development, clinical study designs, trial simulations, analysis methodology and… more
- Merck (Lower Gwynedd, PA)
- …cell-based assays (eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the ... our company training management systems + Operates according to SOPs and safety principles + Ensures SOP compliance (eg, periodic reviews, revisions, and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …activities, assessing issues related to protocol conduct and/or individual subject safety . Assesses overall safety information for studies and compound ... in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of these issues. + Makes final decisions regarding study… more
- CVS Health (Blue Bell, PA)
- …to automate routine data management tasks + Analytical background in pharmacovigilance , Pharmacoeconomics, safety surveillance, and/or outcomes research using ... both remotely and office within the United States. The mission of the Safety Surveillance & Collaboration (SS&C) team within CVS Healthspire Payor & Life Sciences… more
- ICON Clinical Research (Blue Bell, PA)
- …to ensure protocol adherence and quality delivery of study objectives. + Collaborate with Drug Safety teams to assess Serious Adverse Events and contribute to ... the development of Safety Management Plans, Pharmacovigilance Plans, and Risk Management Plans. + Serve as a trusted medical advisor to clients throughout the… more