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HYBRID- Cambridge,MA- PV Aggregate Report Scientist

Company: Real Staffing
Location: Cambridge
Posted on: November 22, 2022

Job Description:

HYBRID- Cambridge,MA- PV Aggregate Report Scientist (RE-33994462) Location:Cambridge, Massachusetts, United States Salary:Up to US$72 per hour + competitive Our client, a leading Biotech manufacturing company is looking for a PV Aggregate Report Scientist. The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team of Global Safety and Regulatory Sciences (GSRS) and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports) and for associated pharmacovigilance
activities for assigned product or group of products, including where required overseeing signal management activities, responses to ad hoc regulatory requests, literature, and clinical trial safety activities.

  • Role: PV Aggregate Report Scientist
  • Contract Type: Hybrid- Cambridge, Mass (50% on site)
  • Start Date: ASAP
  • Rate: $72/hr
    • Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead.
    • Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
    • Support with process improvement; implements and maintains processes. * Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
    • In collaboration with PV Scientist lead coordinates and authors responses to safety questions from regulatory authorities.
    • Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
      • Bachelor's Degree in biologic or natural science Advanced degree (MSc, PhD, MPH, PharmD, etc.
      • Minimum 5 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Cambridge , HYBRID- Cambridge,MA- PV Aggregate Report Scientist, Other , Cambridge, Massachusetts

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