Job Details

  • Title: Epidemiology Consultant
  • Code: RCI-18323
  • Location:
  • Posted Date: 05/15/2020
  • Duration: 7 Months

  Job Description

Major Responsibilities

  • Conduct literature reviews and other background research needed for various regulatory documents and regulatory requests including
  • Epidemiology sections of the Risk Management Plans (RMP), Pediatric Investigational Plans (PIP), Periodic Safety Update Reports (PSUR)/Periodic Benefit Risk Evaluation Reports (PBRER) and orphan drug applications
  • Epidemiology sections for other regulatory documents (e.g. ad-hoc regulatory requests)
  • Provide critical assessment of epidemiological data and literature relevant to safety issues.
  • Produce written summaries of literature assessments, focusing on synthesis of the body of references.
  • Maintain version control of documents and facilitate multiple rounds of review and revision.
  • As needed, conduct quantitative analyses of public use and private data sources
  • As needed, assist Epidemiologist with other Epidemiology deliverables, requiring literature review and summary, for development and product teams, including:
  • Epidemiology Research Strategy
  • Background epidemiology studies, natural history of disease studies and user characterization studies
  • Post-approval safety studies and their feasibility assessments
  • Other epidemiology studies (e.g. special subpopulations, new indications)
  • Support multiple product teams on epidemiology-related issues as needed
  • Work collaboratively with key stakeholders internally and externally
  • Works under supervision of Epidemiologists.

 

 Client Management Responsibilities

  • Safety Risk Leads, Clinical, Medical, Regulatory, Project Management

 

Professional Background and Experience

  • Doctorate degree or Doctoral student in Epidemiology. Will consider MPH degrees with several years of work experience.
  • 1 or more years of work experience in epidemiology (in academia, pharmaceutical, regulatory agency, public sector, or other settings).
  • Familiarity with online medical literature search engines (e.g. PubMed, EMBASE, OVID, TDR’s Incidence Prevalence Database).
  • Ability to critically appraise medical literature and synthesize a large numbers of studies.
  • In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
  • Excellent written and verbal communication skills.
  • Proficient at producing tables, figures, and slides.
  • Ability to manage multiple projects simultaneously