The person hired for this position will be responsible for processing serious adverse events in oncology clinical trials, focusing on the evaluation and reporting of cases in accordance with global safety regulations, departmental standard operating procedures and company policies.  This individual will track cases from receipt to closure, perform verification of safety data and will utilize clinical/pharmacovigilance judgement in coding of serious events and synthesizing complex clinical  information into accurate and complete narratives.  This individual will also maintain accurate and audit-ready files and will interact daily with third-party vendors in the processsing of initial and follow-up information on serious adverse events. 

The responsible person will represent Drug Safety and Pharmacovigilance on assigned Study Teams and will contribute to the development and review of study-related documents including protocols, investigator brochures, informed consents, case report forms, and clinical study reports.  In conjunction with the Drug Safety and Medical teams, they will perform safety review of accumulated safety data from phase I and II clinical trials and assist in the development and maintenance of accurate risk profiles for products in development. 

The responsible person will collaborate daily with Drug Safety colleagues in the development and implementation of effective business processes that maximize efficiency and optimize pharmacovigilance principles.

Job Requirements:

• B.S. (or equivalent) and 3-5 years relevant work experience or RN, Pharm D with 2-4 years relevant work experience
  
• Direct patient-care experience particularly in oncology setting is a plus
  
• Working knowledge of ICH, European Commission, and FDA Guidances and Regulations pertaining to Adverse Event Reporting 
  
• Effective communicator (written and oral); concise, accurate and business appropriate
  
• Excellent attention to detail and effective organization
  
• Critical thinking and problem-solving skills
  
• Ability to manage multiple tasks with deadlines
  
• Works well within teams

Experience in clinical trial safety, working with 3rd party vendors for outsourced safety functions, or supportive roles with IND submissions preferred.