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Global Pharmacovigilance (PV) Scientist

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skill Sets:
  • Experience in Signal Detection and data analysis
  • Review or aggregate data
  • Writing of periodic reports

Day to Day Responsibilities:                
Key Activities Applicable tasks may vary by product(s) assigned.
  • The PV Scientist Manager is responsible for the following:
  • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • In collaboration with the Global Safety Officer:
  • Perform data analysis to evaluate safety signals and write up analysis results.
  • Author Safety Assessment Reports and other safety documents and regulatory responses
  • Document work in the safety information management system (SIMS)
  • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
  • Preparation, writing and review of safety portions of aggregate reports
  • Review clinical trial documents and provide input with regards to safety eg, study protocols, informed consent forms, safety related data collection forms)
  • Attend clinical trial team meetings
  • Aggregate review of Adverse Events/Serious Adverse Events from clinical trials
  • Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
          "This posting is for Contingent Worker, not an FTE"

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