Epidemiology Research Assistant

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.

• 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 (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.

• Ability to collaborate effectively with experts from diverse disciplines No Travel/No Overtime.