Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Develops guidelines and insures the uniform...
Gilead (Drug Safety)
Research Scientist II, Drug Safety Evaluation,
Serves as DSE representative on Discovery Team(s) and nonclinical sub-team member on Development Team(s)
Oversees procedural and scientific aspects of multiple concurrent nonclinical studies throughout drug development...
Sillajen is seeking a detailed oriented, experienced Drug Safety Associate (DSA) to manage operational activities within the PVG and Drug Safety department. Responsibilities will include, but are not limited to: adverse event processing and...
Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product...
Technical Resources International Inc.
The Safety and Pharmacovigilance Specialist will perform various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation, preparation of IND safety reports for submission to the FDA,...
South San Francisco,
The Nonclinical Safety Assessment business area within Translational Sciences is an essential process which assesses the preclinical safety of disease targets and therapeutic molecules. Information technology plays a vital role in this business...
Gaithersburg - Corporate Headquarters,
Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global,...
Note: AstraZeneca is the parent company of MedImmune. Selected candidates will be AstraZeneca Employees and will be located in the Waltham, MA R&D facility outside of Boston, MA.With the aim of improving the quality of our medicines, AstraZeneca...
This position can be based in either of our Thousand Oaks, CA or Cambridge, MA locations. Conducts Amgen safety risk management processes and activities. Ensures that safety risk management (RM) processes are continuously improved to reflect...
Anacor Pharmaceuticals, Inc.
The Associate Director, Drug Metabolism & Pharmacokinetics (DMPK) is responsible for. the nonclinical assessment of New Chemical Entities, which includes lead optimization, ADME, PK/PD, modeling and simulation, GLP bioanalysis, and CRO management of...