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Safety Physician - GPV - Oncology

Northbrook, IL 60062

Posted: 09/21/2018 Employment Type: Contract Industry: Other Area(s) Job Number: 22954
  • Participate in or lead safety management teams for clinical programs. 
  • Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs) 
  • Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk. 
  • Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed. 

Create, or assist in creating: 
  1. PBRERs, DSURs, PADERs 
  2. Signal detection activities 
  3. Create and/or review safety portions of submission documents 

Requirements: 
  • Physician with relevant, hands on safety experience. 
  • At least 3 years of hands on PV experience in clinical and/or post marketing 
  • Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV 
  • Hands on experience writing/reviewing Aggregate Reports, e.g., PBRERs, DSURs, and PADERs 
  • Hands on experience with signal detection activities such as analyzing/categorizing/ 
  • assessing data 
  • Strong leadership skills 
  • Excellent oral and written communication skills 
  • Excellent listening and comprehension skills 
  • Ability to work effectively in a matrix setting to resolve issues and achieve common goals
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