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Job Title :Senior Consultant – Safety Signal Detection
Location:Preferably Foster City / Freemont, CA. Remote option available
Duration:6 months / Contract to Hire
Qualifications Required:Bachelor’s degree in Computer Science or Engineering and/or equivalent experience/training
Job Description :

Responsibilities:

  • 8+/extensive technical and functional knowledge of Global Pharmacovigilance IT Systems like Argus Safety, Argus-J, AEGIS (Adverse Event Gathering and Integration System), AIR (Argus Internal Reports), HDR (Healthcare Data Repository) and ESS (Empirica Trace) and other commercially available drug safety system.
  • Experience in the implementation of signal detection functionality to pharmaceutical /biotechnology companies / regulatory agencies in the areas of clinical development and post-marketing.
  • Hands on experience with IT system assessment and comparative analysis, business data modelling and business process modelling.
  • Ability to perform IT System Assessment, Regulatory Assessment, Personal and Security Assessment, conduct impact analysis and author assessment report/recommendation roadmap.
  • Extensive experience in complete SDLC implementation of many large and medium-sized projects.
  • Ability to understand large complex processes with a focus on improvement and awareness of emerging trends.
  • Apply enthusiasm and interest in all computer related activities.
  • Must be able to lead requirement workshops, design, prototype, configure and document effective solution.
  • Must have strong presentation, technical writing skills, analytical skills
  • Strong networking skills and being proactive with the ability to work independently as well as have ability/willingness to work in a global environment with product vendors and other partners.

Good to have / desirable experience:

  • Direct experience in ‘time-boxed’ strategic consulting engagements
  • Direct experience with performing a medical assessment of individual case safety reports (ICSRs) to determine seriousness, expectedness, and causality of adverse events.
  • Direct experience with performing signal detection and analysis activities e.g. managing and tracking signals, identify potential signals, validate and perform the signal assessment.
  • Experience in data mining methods for detection and evaluation of safety signals.
  • Experience in authoring safety aggregate reports like PSUR, DSUR, Risk Evaluation, and Management Strategy(REMS).