Clinical Safety Monitor

Description

About Hollis-Eden Pharmaceuticals:

Hollis-Eden Pharmaceuticals’ innovative science has attracted the industry’s most creative and successful employees.  Our culture promotes leadership by empowering people to expand their ideas and break through existing performance boundaries.  We are dedicated to reaching ambitious goals through the combined collaborative effort of our people, resulting in a culture of ownership and achievement. 

 

Primary Responsibilities:

You will utilize your industry experience and expertise to analyze, report and resolve issues relating to Adverse Events, especially SAE’s within our drug development organization.  Your thorough knowledge of all applicable government regulations, as well as the ability to exercise good judgment in evaluating situations and in making decisions concerning safety reports and administrative issues will be key to your success in this position.  It is expected that you will provide training to site personnel responsible for the reporting and documentation of Serious Adverse Events.

 

You will help develop company SOPs and process all AE reports coming from multiple sources to assure compliance with both company SOPs and FDA regulations for the reporting of AE’s to regulatory agencies.  You will conduct AE investigations using medical expertise to ensure that all appropriate information are gathered and followed up on through to resolution.  You will communicate with physicians and healthcare facilities requesting medical records and/or follow-up information as needed.  Further, you will assess each reported AE for serious, non-serious, expected, and unexpected criteria as per FDA regulations and company study protocols. 

 

You will work closely with all clinical employees to report, assess and resolve all safety issues on individual AE reports.  You will review and monitor data to follow AE signals/trends and bring to the attention of the management any potential or significant safety concerns as well as assisting in the preparation, compilation and submission of AE reports for company management.  You will create clear, logical and sound narratives and will validate summaries of AE reports. You will assist with the preparation of IB and IND annual updates. You will perform body system coding for Adverse Events, medical history and concomitant medications for human clinical trials.  You will assist in the development of Clinical Study Reports and Case Report Forms for the clinical trials. You may represent the Clinical department at investigator meetings and provide back-up support to Clinical Data Management when necessary.

 

Requirements:

Minimum Requirements:BS degree in Pharmacy/Nursing with a minimum 2/5 years clinical/safety experience in drug development organizations.Excellent verbal and written communication skills.Proficiency in medical writing: excellent degree of accuracy with attention to detail.Able to maintain and enhance co-operative working relationships with internal and external groups such as CRO’s and outside laboratories.  Ability to resolve issues (internal and external) in an appropriate and mutually acceptable manner.Ability to handle multiple tasks, prioritize assignments, structure workflow and meet tight deadlines.Proficient in the standard Microsoft Office applications, as well as up-to-date in appropriate medical/clinical database and on-line tools. 

Please submit your resume as a Word Document with CSM-MOS in the subject line to, jobs@holliseden.com

 

Compensation and Benefits:We offer a competitive benefits package including stock options and a 401k plan.