Posted to MedZilla on 3/24/2019

Randstad Pharma

Pharmacovigilance 20441-MZ


Job Title: Safety Physician I (GPV)

Position Description

  • Participate in or lead safety management teams for clinical programs.
  • Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs)
  • Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/ris

Position Responsibilities

  • Create, or assist in creating:

    • Signal detection activities
    • Create and/or review safety portions of submission documents
  • Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.

Position Requirements

  • Physician with relevant, hands on safety experience.
  • At least 3 years of hands on PV experience in clinical and/or post marketing
  • Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV.
  • Hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs.
  • Hands on experience with signal detection activities such as analyzing/categorizing/assessing data.
  • Strong leadership skills.
  • Excellent oral and written communication skills.
  • Excellent listening and comprehension skills.
  • Ability to work effectively in a matrix setting to resolve issues and achieve common goals.


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

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