Outputs:
- Strategies for and delivery of epidemiologic programs, including external database analyses, post-authorization safety & efficacy studies.
- Epidemiology components of R&D documents, including global regulatory submissions, Developmental/Risk Management Plans (including REMS).
- Safety Topic Review background epidemiology.
- Evaluation of signal detection methodologies.
- Key, high value Presentations and Publications.

Knowledge:
- Product development.
- Epidemiological / analytic methodologies.
- Depth regarding disease natural history in areas such as oncology / hematology/inflammation/immunology.
- International Drug Safety Regulations.

Competencies
- Leadership.
- Organisation and planning.
- Communication (written & oral).
- Team work.
- Information analysis skills.
- Data representation skills.
- Staff Management

Qualifications
Qualifications
- Ph.D. in epidemiology
- MD/PhD combination optional

Experience
- Ten (10) years relevant experience, including training.
- Six (6) years industry epidemiology experience.
- Drug safety experience required.
- Strong publication track record.