Pharmacovigilance

  • location: Cambridge, MA
  • type: Contract
  • salary: $55.80 - $65.65 per hour

job description

Pharmacovigilance

Pharmacovigilance Specialist

Job Responsibilities

  • Contributes to production of high quality of aggregate report, Safety Review meeting coordination, signal detection activities, and clinical development and product registrational activities.
  • Oversees and assumes responsibility for assigned therapeutic products and PV activities through the lifecycle of the product.
  • Supports an organizational structure that meets the evolving needs of Shire and the GDS department.
  • Fosters a collaborative culture within the product team and to external stakeholders.
  • Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where the client is the Global Safety Database holder.
  • Creates, coordinates, prepares and completes aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world.
  • Collaborates with the Global Safety Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment.
  • Responsible for the quality of the final document and uses the client's EDMS system to provide quality control.
  • Provides the technical and scientific support for safety surveillance and signal detection activities for assigned client products via established signal detection methodology and tools.
  • Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities.
  • Responsible for efficiently planning Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
Benefits

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