- Sanofi Group (Cambridge, MA)
- …teams (business, commercial, medical affairs, clinical affairs, cybersecurity, privacy, pharmacovigilance , legal team and more) to deliver safe and effective ... products that excel in performance and usability. + Monitor and analyze product performance to assess solution effectiveness and drive product adoption in the field. + Stay informed about the latest advancements in patient find and diagnostic technologies,… more
- Takeda Pharmaceuticals (Boston, MA)
- …project management, clinical monitoring, data management process, regulatory affairs, pharmacovigilance , etc.) to enable meaningful dialogue within Takeda and with ... partners. + Proven experience in Alliance/Partnership excellence: deep understanding/experience of building, maintaining, and closing partnerships including tools/methods. + Expertise in the ability to perform root cause analysis, develop corrective actions,… more
- Takeda Pharmaceuticals (Boston, MA)
- …compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. + Oversees ... and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. + Responsible for evaluation of external interactions in the context of overall development… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compounds in conjunction with Pharmacovigilance . + **External Interactions** + Directs activities involved in interactions ... with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these… more
- Sanofi Group (Cambridge, MA)
- …benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify, ... monitor and resolve clinical program/trial issues. + Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data. + Provide appropriate medical input & support for all activities related to clinical studies… more
- Sanofi Group (Cambridge, MA)
- …input into development plans + Support due diligence activities and pharmacovigilance agreements **Signal Detection & Assessment** + Responsible for signal detection ... and analysis + Collaborate with Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group + Identify and implement proactive safety analysis strategies to further define the safety profile + Lead aggregate safety data review… more
- Sanofi Group (Cambridge, MA)
- …the relevant product life cycle stage of the asset, eg Regulatory, Pharmacovigilance , Key Market Medical asset leads, Scientific Communications teams etc to ... co-ordinate and execute the approved activities of the Global Medical Action Plans. These could include approved IEGP studies, priority data dissemination activities, launch execution activities under Medical accountability, and other key medical program/… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …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 issues. + Makes final decisions regarding study conduct related to scientific integrity. External Interactions + Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area.… more