Drug Safety Associate

  • location: Northbrook, IL
  • type: Contract
  • salary: $55 - $60.81 per hour
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job description

Drug Safety Associate

job summary:




Job Title: Jr. PV Scientist (GPV)

Position Description

  • Support PV product responsible teams and participate in development core teams and core medical teams.
  • Conduct ongoing monitoring and assessment of the safety profile of assigned Company developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 - Phase 3 clinical trials and Post-Authorization Studies.
  • Perform timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigators Brochure and local product labeling.
  • Contribute to the design of safety surveillance strategies and manage safety signals for Company drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs).
  • Support risk management of assigned Company drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders.
  • 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 Medical Safety to ensure appropriate safety context is conveyed.
  • Coordinate, monitor and assess the safety profile of one or more specific Company products assigned to the Global TA under supervision of the TA group lead or TA team lead.
Position Requirements

  • Bachelor's degree in a scientific, health-related field
  • 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
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


 
location: Northbrook, Illinois
job type: Contract
salary: $55.00 - 60.81 per hour
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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