Senior Safety Specialist - remote

Company: Precision For Medicine
Location: Orlando
Posted on: May 16, 2022

Job Description:

Senior Safety Specialist is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.

Position Summary

Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

Essential functions of the job include but are not limited to:

• Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems
• Participate in the assessment and set-up of a safety database to capture SAE data
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures
• QC of documents and safety reports
• Preparation and/or review of project-specific safety reporting plans and medical coding plans
• Preparation and/or review of safety training materials
• Provide safety training and oversight for consultants, contractors and/or staff
• Review and/or draft standard operating procedures and work instructions
• Assist clients and/or other departmental staff with safety-related reviews and other services
• Other duties as assigned
  Minimum Required
  
  Qualifications:
  
  BA/BS degree
  
  • Minimum 3 years clinical safety experience
    Other Required
    
    Health care professional
    
    • Hands on experience with global safety database(s), SAE case processing, and safety reports generation
    • Working knowledge of MedDRA and WHODrug
    • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations
      Preferred
      
      • Nursing or pharmacy degree
      • Industry experience in CRO or pharmaceutical company
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        Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. - 2020 Precision Medicine Group, LLC
        
        If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision For Medicine, Orlando , Senior Safety Specialist - remote, Other , Orlando, Florida