Safety Aggregate Report Specialist

Safety Aggregate Report Specialist page is loaded## Safety Aggregate Report Specialistlocations: Pasig, Philippinestime type: Full timeposted on: Posted Todayjob requisition id: R **Job Overview** Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. **Essential Functions*** Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).* Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings* Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.* Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the ident...