- ThermoFisher Scientific (Waltham, MA)
- …safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on - now ... patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes. \#CorEvitas Discover Impactful Work: The Biostatistician will… more
- AbbVie (Mettawa, IL)
- …closely with cross-functional teams - including Commercial, Market Access, Regulatory, Safety , and Clinical Development - to support the product lifecycle, from ... ethical standards. . Collaborate with Regulatory Affairs, Legal, Compliance, and Pharmacovigilance teams to ensure adherence to internal processes, policies, and… more
- Sanofi Group (Morristown, NJ)
- …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
- AbbVie (Florham Park, NJ)
- …(medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). ... role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of… more
- University of Pennsylvania (Philadelphia, PA)
- …and NIH and NCI mandates. + Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety ... Additional experience in clinical research ie Data Management, Project Management, Drug Safety are a strong plus. The appropriate candidate will possess a thorough… 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
- Takeda Pharmaceuticals (Boston, MA)
- …activities, assessing issues related to protocol conduct and/or individual subject safety . Assesses overall safety information for studies and compounds ... in conjunction with Pharmacovigilance . + **External Interactions** + Directs activities involved in interactions with regulatory authorities/agencies and clinical… 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 and, as applicable, medical directors with respect to assessment of these… 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
- Bristol Myers Squibb (Seattle, WA)
- …Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing ... external communication when significant safety issues arise, with the well-being of patients being the goal + Understands and adheres to the BMS Standards of… more