Job Description-
• 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.
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), Paediatric 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.