Job Description
US Drug Safety Consultant II/PV Scientist
PV Scientist serves as a product lead for Pharmacovigilance activities within Safety. The PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities. The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
What You'll Do Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, ...