Senior Pharmacovigilance Scientist

The Role:The Sr. Pharmacovigilance Scientist plays a critical role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. The Sr. Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will be responsible for leading and/or contributing to activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational products, this role may also encompass contributions to protocol design, safety CRFs, IB/RSI, ICF, SMP, DMC materials, coding reviews, and safety analyses for CSRs, as applicable. The Sr. Pharmacovigilance Scientist will also support process improvement initiatives, including updates to SOPs, WIs, 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. The position will report to the Associate Director, Risk Management Lead and will be located in the Waltham, MA office. Key Responsibilities:  Coordinate and document signal management activities with the product Safety Physician. This includes performing signal evaluations and drafting signal investigation 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. Coordinate RMP updates and REMS reports as appropriate. Support regulatory submissions for new products, formulations or indications (NDA, MAA, etc.) in partnership with the Safety Physician and other cross-functional experts. Manage literature surveillance for marketed products and medicinal products under development, as applicable.  Prepare materials for Safety Committee meetings in conjunction with the Safety Physician and document/archive meeting minutes.  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 remain 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 initiatives and consistency of cross-product processes. Train and mentor junior members of the team. Maintain inspection readiness. Perform other tasks as assigned or required.