PRAHS

2017-42476

- | US-IL | US-Remote | US-MA-Boston
2 weeks ago
Title
Associate Director, Medical Review - Cambridge, MA or Deerfield, IL

Overview

The Associate Director of Medical Review will lead oversight of outsourced medical review of individual case safety reports for assigned products. They will provide medical expertise and guidance to the case management team to ensure medical accuracy of all aspects of the output. Develop procedures in support of the Global Safety department having a significant medical context. Ensure timely escalation of cases and safety issues to the stakeholders as appropriate. Contribute to the medical management of AE reports and perform Medical Review.

Responsibilities

Responsibilities:

  • Lead and perform medical review, including oversight of outsourced medical review of seriousness, expectedness/listedness, causality, coding, and narratives of individual case safety reports for investigational and marketed products
  • Lead and direct the medical input and guidance for ad-hoc queries for ICSRs
  • Lead and direct the preparation, authoring, and approval of analysis of similar event reports for SUSARs from clinical study as per company convention
  • Lead and direct medical oversight and guidance to vendors performing case processing including required training
  • Lead and implement with alliance partners harmonization and industry standard medical review and case assessment standards
  • Perform other  duties as assigned by the Head of Global Medical Review to support PV activities

Qualifications

Knowledge, Skills, and Abilities:

  • Critical thinking and analytical skills and ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
  • Good level of computer literacy with Microsoft applications

Education/Background:

  • Minimum 2 years experience in Pharmacovigilance including medical review of individual case safety reports
  • Minimum 8 years pharmaceutical or health care related industry experience
  • 5 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Qualified physician (medical doctor) or pharmacist from an accredited institution
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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