Associate Pharmacovigilance Scientist

About This Role The Associate PV Scientist serves as a critical team member within the Safety Surveillance and Aggregate Report (SSA) team for products or product groups, including supporting with signal management activities, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, and conducting safety literature reviews.  The role will cover activities relating to marketed and/or investigational products.What You’ll Do Supports Signal Management activities in collaboration with, and oversight from, the PV Scientists:Evaluate safety data and conduct signal management activities. This may include updates to signal detection plans, contribution to or authoring of meeting reports, presentations and minutes, and may also include authoring sections of signal evaluation reports.Support updates to RMPsCollaborate with Global Safety Officers (Safety physicians)Represent SSA in cross functional meetings with other departments, such as Regulatory and Clinical DevelopmentPerform ICF review, AE coding review and other clinical trial safety-related activitiesConduct literature reviewGeneral administrative tasks (request subject matter experts for information, scheduling of activities, providing information for trackers, requesting database outputs)Supports Aggregate Report preparation in collaboration with the PV Scientists:Supports with the preparation of aggregate safety reports such as PSURs, DSURsPerform data review and verification:Technical and scientific reviews including source data verificationEditorial review; ensure grammatical and stylistic consistency and accuracyFormatting, internal linking, and external cross-referencingSupport with Quality Checks for documents authored within the SSA team