Manager, Global Risk Management & Safety Surveillance Scientist

Job Summary (Primary function)

This Global Risk Management & Safety Surveillance (GRMSS) Scientist collaborates with the GRMSS Physicians and GRMSS Scientists to characterize the evolving clinical and post-marketing safety profiles for investigational drugs and/or products, based on analysis of aggregate data sets from internal or external sources and the medical literature. This entails drafting, reviewing, and refining portions of periodic aggregate safety reports (including DSURs, PADERs/PAERs, and Risk Management Plans (RMPs)). The GRMSS Scientist performs the signal detection activities and review process for clinical data, including signal detection, evaluation, and verification;potential sources of data for signal detection include external marketing partners, or contracted business entities. The GRMSS Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners.