Signal Detection/Drug Safety Associate II Job at Integrated Resources, Bridgewater, MA

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  • Integrated Resources
  • Bridgewater, MA

Job Description

Signal Detection/Drug Safety Associate II

Contract

Job Title: Signal Detection/Drug Safety Associate II

Responsibilities


  • The contractor resource will be the key contact on the SM Simplification Project work streams.
  • Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team.
  • Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
  • Assess currently utilized quality documents and develop/modify business processes as needed.
  • Develop training materials and provide training.
  • Develop and implement a consistent process to produce KPIs.
  • Work closely with PM to ensure that timelines are met.
  • Coordinate and lead SMC meetings.


Qualifications
  • Experienced in signal detection tools and processes
  • Skilled in implementing new business processes and technology solutions for signal detection in clinical development
  • Experienced in LEAN methodology
  • Working knowledge of regulations related to signal detection (GVP Module IX)
  • Proven expertise working with FAERS and WHO-Vigibase data
  • Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process
  • At least 5+ years of pharmacovigilance experience, especially in signal detection and management
  • Strong consulting experience
  • Excellent Excel/WP/PowerPoint and technical writing skills
  • Clinical experience a plus



Education

Education:

#J-18808-Ljbffr

Job Tags

Contract work, For contractors,

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