Global Safety Officer (Pharmaceutical)

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Irfa******

  • United States 
  • Last Update: 15.12.2018 at 12:00

Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Bridgewater, NJ, US
Country
United States

Category


Research & Development (R&D)

Description


Job Description The Global Safety Officer will be responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations. Key responsibilities include:
    • Routine safety surveillance/signal detection
    • Labelling
    • Medical literature review
    • Contribution to/Creation of regulatory responses
    • Review of outsourced reports
  Qualifications
  • 6 - 9 years of experience in reporting/submission of safety information related to drug products
  • Must be a Health Care Professional, ideally a Physician
  • Excellent verbal and written English communication skills
  • Global pharmacovigilance experience
  • Consumer health background
  • Ability to make quick assessments to meet strict deadlines
  • Medical writing/literature review experience

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