Safety Physician I (GPV)

  • location: Northbrook, IL
  • type: Contract
  • salary: $77.53 - $91.22 per hour
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job description

Safety Physician I (GPV)

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

 
location: Northbrook, Illinois
job type: Contract
salary: $77.53 - 91.22 per hour
work hours: 9 to 5
education: Doctorate
 
responsibilities:
  • 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.
  • Create, or assist in creating:

    • PBRERs, DSURs, PADERs
    • Signal detection activities
  • Create and/or review safety portions of submission documents
  • Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.
 
qualifications:
  • 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
 
skills: Pharmacovigilance, Drug Safety, DSUR (Development Safety Update Report), Regulatory Affairs Operations, Submissions, PBRER (periodic Benefit Risk Evaluation Report)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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