Associate Director, Senior Patient Safety Scientist

Job description

Introduction: The Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist . He/she authors and leads PV input to safety documents and regulatory reports. Associate Director, Senior Patient Safety Scientist leads meetings and presents safety data and analyses. Main Responsibilities: Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of G lobal Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate . Leads PS activities o f cross-functional project teams for developmental compounds and/or marketed products. Leads and provides safety expertise to I nvestigator B rochures, P rotocols, I nformed C onsents and C linical S tudy R eports. Has the ability to perform duties as a Safety Strategy and Management Team ( SSaMT ) L eader for larger or more complex projects . Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead...