Professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred; or M.D. or D.O. strongly preferred (certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
Pharmaceutical industry experience in a relevant therapeutic area.
Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with Bachelor’s or Master’s degree, in the pharmaceutical industry in the area of pharmacovigilance, more specifically within medical safety science functions.
Direct exposure to pharmacovigilance functions is a must; additional regulatory and/or clinical development experience is a plus.
In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
Experience in planning, allocating and managing multiple projects.
Demonstrated capabilities in independently conducting complex analyses and working with large datasets.
Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.
Ability to work within a matrix environment.
Strong skills in Excel and Word.
Strong skills in scientific writing.
Fluent in English, both written and verbal.