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Patient Safety Physician Freelance

Patient Safety Physician Freelance

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Patient Safety Physician Freelance

  • Location:

    United States of America

  • Sector:

    Pharma, Pharmacovigilance - Pharma

  • Contact:

    Edward Jessel

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    EJ-PSP_1634026533

  • Published:

    14 days ago

MSI Pharma are currently working with a mid-sized Global Pharma based in New Jersey to hire a Director level Freelance Safety Physician with experience undertaking benefit and risk analysis activities.

The ideal candidate will have:

  • Medical degree
  • 5+ years' experience in Drug Safety
  • Experience working on Benefit and Risk analysis activities
  • Experience working in a Pharma or Biotech company

Main job activities:

  • Conducting medical assessments, on-going safety evaluation and signal detection as part of the global Pharmacovigilance organization
  • Interacting with EMA, NCAs, Region Europe Affiliates, partners and service providers about safety issues
  • Contributing to and reviewing key pharmacovigilance documents such as PADER, DSUR, PBRER/PSURs, CCSIs, Risk Management Plans, safety sections of SmPCs, IBs, Clinical Trial/ Study Protocols, and Final Reports
  • Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
  • Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues

KEY WORDS: Pharmacovigilance, Physician, Freelance Job, Benefit:Risk, Drug Safety, PV, Clinical Safety, Clinical Development