- AbbVie (North Chicago, IL)
- …core R&D sub-functions, including Clinical Pharmacology & Pharmacometrics, Pharmacovigilance , Medical Affairs, Regulatory Affairs, and Clinical Development (both ... review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Partner with Clinical...+ Participate in design and execution of clinical trial safety , product safety , and risk management plans.… more
- AbbVie (North Chicago, IL)
- …core R&D sub-functions, including Clinical Pharmacology & Pharmacometrics, Pharmacovigilance , Medical Affairs, Regulatory Affairs, and Clinical Development (both ... review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical...+ Participation in design and execution of clinical trial safety , product safety and risk management plans.… 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 ... Oversight:** Ensuring independent quality oversight of Clinical and Post-Marketing Safety , Regulatory Affairs, and Medical Affairs activities throughout the product… more
- Takeda Pharmaceuticals (Boston, MA)
- …that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder ... and activities that support Takeda regulatory commitments including submission of safety data. + Liaise with cross functional and technology senior leaders… more
- Sanofi Group (Cambridge, MA)
- …Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. ... needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities… more
- Bausch + Lomb (Montgomery, AL)
- …Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug/Device Safety , and Clinical Supplies), ... and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs 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
- 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 ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …monitoring 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… more
- Takeda Pharmaceuticals (Boston, MA)
- …activities, assessing issues related to protocol conduct and/or individual subject safety . Assesses overall safety information for studies and products ... in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of these issues. + Makes decisions regarding study conduct… more