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Senior PV Scientist Apply Now

Location: Waltham, Massachusetts 02451
Employment Type: Contract

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Job Description

Contract Length:  6 months, hybrid position

Job Summary:  The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD for assigned investigational and/or marketed product(s).  

Responsibilities:
 
  • Serve as key analytic and safety support lead in close collaboration with the product safety physician for the assigned product(s)
  • Responsible to analyze potential safety issues, including signal detection, signal evaluation and signal management. This includes coordination and documentation of all signal review activities.
  • Contribute to signaling and data mining activities utilizing internal and external sources of data 
  • Coordinate with Safety physician to lead Safety Committee meeting preparation and documenting of meeting minutes
  • Performing sponsor review of serious adverse events outsourced to our PV vendor
  • Responsible for safety review of protocol and CRFs, safety content of IB, ICF, and other documents to appropriately support Clinical study activities. 

Requirements:

  • Advanced degree (PharmD, RN, MD, PhD, MPH, NP)
  • Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.
  • Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.
  • Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
  • Strong organizational, project management and leadership skills

Contact

Christian Griffith
Principal Recruiter


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