Remote Medical Safety Specialist

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Feb 17, 2021

This job expires in: 20 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Staffing Agency

Career Level: Experienced

Job Summary

A clinical and scientific staffing company is filling a position for a Remote Medical Safety Specialist.

Core Responsibilities of this position include:

  • Perform medical interpretation and analyses of safety data, including both ICSRs and aggregate data
  • Support of writing and review regulatory documents, including periodic reports, signal evaluation reports and other analyses
  • Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs)

Skills and Requirements Include:

  • 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 global regulations impacting Pharma industry, 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

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