- 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