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...
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...
Ultragenyx Pharmaceutical Inc.
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded...
•The Drug Safety Response Associate is the key player in the procurement of vital follow-up Adverse Event information in order to facilitate the process of case evaluation and assure compliance with regulatory authorities. The individual must...
Halozyme Therapeutics, Inc.
The Drug Safety Manager oversees drug safety and pharmacovigilance activities, including ensuring timely processing and submission of adverse event reports in compliance with global regulations for marketed products and...
We are looking for a Senior Clinical Safety Specialist with some or most of the following characteristics: Sound ability to communicate effectively in a matrix environment* Ability to multi-task* Solid written and oral communication skills*...
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our...
Novartis Institutes for BioMedical Research
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most...
Position Summary: This position is responsible for providing administrative and clerical support to the Senior Vice President, Clinical Development and the Vice President, Clinical Development.
• Routine monitoring and review of SAE...
Seattle Genetics, Inc.
Safety Physician, Safety Evaluation & Risk Management (SERM) The Medical Director SERM will be responsible for signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seattle Genetics, Inc....