Drug Safety Specialist III

San Francisco, California 94158 | Contract

Post Date: 05/22/2018 Job ID: 4289 Industry: Pharmaceutical

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. 

 

Duties:
  • 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. 
  • Insures the uniform and timely processing of adverse event reports.  
  • Develops and prepares reports for company management as well as external regulatory agencies. 
  • May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.

 

Skills:
  • Performing complete data entry of serious adverse events received from clinical trials, according to the workflow processes and standard operating procedures.  
  • Generate accurate and complete case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites. 
  • Draft appropriate queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Drug Safety person. 
  • Communicate or notify drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. 
  • Maintain and track all serious adverse events reported from sponsored clinical trials for case processing relative to their priorities and submission deadlines.   
  • Support Drug Safety Department initiatives on ad hoc (as needed) basis.  
  • Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. 
  • Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally.  
  • Ensure compliance with SOPs.

 

Education:

  • A Bachelor's degree in a scientific discipline is preferred.
  • RN or BSN degree is highly desired.
  • Equivalent experience may be accepted.
  • A minimum of six years experience in Drug safety or Pharmacovigilance, with at least two years hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required.  
  • Experience in oncology therapeutic area is preferred but not mandatory. 
  • Familiarity with Medical terminology required. 
  • Ability to process data entry accurately. 
  • Ability to code and map data accurately. 
  • Concise case narrative (medical) writing experience preferred. 
  • Ability to prioritize work without much support.  
  • Clear effective written and verbal communication skills are essential for effective communication with study sites. 
  • Focused and detail oriented. 
  • Work effectively as a team member, promote collaboration. 
  • Self starter and self accountability. 
  • Relevant industry experience is highly preferred. 
  • High level of work conduct.
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