Pharmacovigilance Scientist

The Pharmacovigilance Scientist serves an integral role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. The Pharmacovigilance Scientist is expected to be equally effective working collaboratively and independently. She/he will support activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and other safety analyses; and must ensure deliverables are of high quality and are completed according to required timelines. For investigational products, this role will contribute to safety review and analysis for clinical trial documents. The Pharmacovigilance Scientist will also support the maintenance of relevant SOPs, Work Instructions, and other documents.The successful candidate will have demonstrated adequate prior experience of the above responsibilities. Key indicators of success in this role include accountability, attention to detail, appropriate prioritization, management of assigned projects with quality and timeliness, and effective communication.This position will report to the Sr. Pharmacovigilance Scientist and will be located in the Waltham, MA office/Remote.What You’ll Do:Coordinate and document signal management activities with the product Safety Physician. This includes performing signal evaluations and drafting signal evaluation reports. Prepare aggregate safety reports (e.g. DSURs, PADERs, PBRERs), including project management, database requests, data analysis, report authoring, assimilating information from other groups, review coordination, and quality checks.Support RMP updates and REMS reports as appropriate.Perform literature surveillance for marketed and investigational products .Prepare materials for Safety Committee meetings in conjunction with the product Safety Physician and document/archive meeting minutes and materials.Coordinate responses for ad hoc safety queries in conjunction with the Safety Physician and other cross-functional experts, including data analysis and authoring, as applicable. Support review and analysis of safety content for study protocols, CRFs, IB/RSIs, ICFs, SMPs, CSRs, DMC meetings, and coding reviews, as applicable.Demonstrate knowledge and stay up to date to ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)Contribute to process improvement and consistency of cross-product processes.Maintain inspection readiness.Perform other tasks as assigned or required.