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Director, Medical Reviewer

LanceSoft, Inc.

Key Facts

Remote From: 
Massachusetts (USA)
Full time
Expert & Leadership (>10 years)
English

Other Skills

  • •
    Safety Assurance
  • •
    Analytical Skills
  • •
    Communication
  • •
    Detail Oriented
  • •
    Computer Literacy
  • •
    Mentorship
  • •
    Training And Development
  • •
    Collaboration
  • •
    Social Skills
  • •
    Critical Thinking
  • •
    Multitasking
  • •
    Time Management

Roles & Responsibilities

  • Medical degree required or internationally recognized equivalent
  • Minimum 10 years pharmaceutical or health care related industry experience
  • 5 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Minimum 5 years experience in Pharmacovigilance including medical review of individual case safety reports

Requirements:

  • Oversee medical assessment of individual case safety reports in the Global Safety Database
  • Ensure compliance with domestic and international regulations
  • Communicate effectively with internal and external stakeholders regarding safety assessments
  • Mentor and train new or junior colleagues

Job description

Job Description:
Objectives/Purpose
  • The Director, Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed product across all therapeutic areas.
  • Responsible for overseeing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations.
  • Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to queries

Accountabilities
  • Oversight of global medical review of individual case safety reports for Client investigational and marketed products from all sources includes but not limited to the following:
  • seriousness criteria confirmation and expectedness/listedness assessment review of the reporter’s causality and company causality assessment event confirmation and coding as per convention, analysis of similar events as required, provide sound rationale in Company
  • Comment regarding causality, ensure due diligence in adequate follow-up, and timeliness of expedited reports
  • Collaboration with other PSPV personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of Client products.
  • Establish with alliance partners harmonization and industry standard medical review and case assessment standards
  • Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queries
  • Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
  • Compliance, consistency and timely medical review
  • Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames.
  • Partners with safety operations teams to ensure consistency of work practices and SOPs.
  • Mentoring and training of new and or junior colleagues
  • Work with the Head of Medical Safety Review to implement and augment onboarding and training processes
  • Performs such other duties as requested by management
  • Multi-tasking with the ability to successfully manage multiple critical issues simultaneously Demonstrate integrity
  • Work productively in a high pressure environment
  • Good analytical,judgment critical thinking capabilities to understand/analyze/synthesize and communicate
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Attention to details, computer literacy, knowledge of safety database
  • Take initiative in collaboration with management ]
  • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills

Education, Skills:
  • Medical degree required or internationally recognized equivalent.
  • USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.
  • Minimum 10 years pharmaceutical or health care related industry experience
  • 5 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Minimum 5 years experience in Pharmacovigilance including medical review of individual case safety reports
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