Job Title: Director, Clinical Safety Job Description The Director, Clinical Safety will be responsible for leading... across clinical studies, post-marketing surveillance, signal detection, and regulatory submissions. The Director will ensure proactive...
and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving... global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow Plans...
of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. Responsibilities Change Requests..., Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence Review...
Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical...). If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned clinical study...
Director, Clinical Development Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group...) and CSR safety narratives May lead the development and updates of the Investigator’s Brochure (IB): author the clinical...
The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical... studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director...
Job Title: Temp - Associate Director, Clinical Sciences, Hematology Location: Remote, US Contract: Initial 6-12... month contract Job Description: The Temp Associate Director, Clinical Scientist contributes to the development...
development projects through early and/or late phase development. Reports to the Senior Director, Clinical Sciences... and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise vital to design and deliver on clinical studies...
through early and/or late phase development. The Sr. Manager reports to the Director, Clinical Sciences and collaborates... closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies...
: 12 months Duties: This position of Associate Director has responsibilities as a safety data scientist in Epidemiology... Analytics group of Clinical Safety and Pharmacovigilance (CSPV) at the company. This position uses and analyzes both clinical...
Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational... to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical...
and the contractual obligations that govern the exchange of safety data between partners in relation to marketed and clinical..., WHO-DD) - Knowledge of FDA and global PV regulations, clinical and safety databases - Familiarity with Good Clinical...
for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high... cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety and Pharmacovigilance...