Description
Duties:- Provides epidemiologic input into strategic documents, including regulatory filings (NDA, PSUR, etc)
- Contribute to Risk Management Plans (DRMP, RMP, REMS, etc) for products throughout lifecycle
- Performs systematic literature reviews
- Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software
- Provides epidemiologic strategy to estimations of the target population
- Designs and produces protocols for observational studies using automated data or primary data collection
Skills:
- Essential to have in-depth knowledge of clinical trial design and epidemiological data analysis as well as broad understanding of data management, biostatistics, statistical programming, drug safety and pharmacovigilance.
- Excellent verbal and written communication.
- Outstanding organizational, interpersonal, influencing, scientific writing and presentation skills.
- Good project management skills
- Experience in applying epidemiologic and pharmacoepidemiologic methods in the pharmaceutical industry and using of large, automated databases for general epidemiology and drug safety analyses.
- Experience in pharmacovigilance regulations, processes, and procedures.
- Experience with data mining software is a plus
Education:
- Master's or doctorate degree in epidemiology or MD with Master's degree in
epidemiology or public health preferred - 5+ years of experience in
pharmaceutical/biotechnology industry, CRO, or drug development company
To find out more about Real please visit www.realstaffing.com