Epidemiology Research Assistant

MAJOR RESPONSIBILITIES

- Including - Epidemiology sections of the Risk Management Plans (RMP), Pediatric Investigation Plans (PIP), Periodic Safety Update Reports (PSUR)/Periodic Benefit Risk Evaluation Reports (PBRER) and orphan drug applications
- Epidemiology sections for other regulatory documents (eg 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 (eg 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.

SKILLS:

PROFESSIONAL BACKGROUND AND EXPERIENCE

- Doctorate degree or Doctoral student in Epidemiology
- 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 (eg 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
- Ability to collaborate effectively with experts from diverse disciplines
- Epidemiology