Senior Manager, Pharmacovigilance Operations

Axsome Therapeutics is seeking a Senior Manager, Pharmacovigilance (PV) Operations to develop KPIs which are relevant to measure quality of the PV system. The Senior Manager, PV Operations is responsible for oversight of the PV Compliance system, including monitoring case processing KPIs, monitoring ICSR submission timeline, monitoring ICSR reconciliation activities, creating and maintaining SOPs and / or WIs, contractual agreements involved PV activities, facilitating the periodic safety report activities, and ensuring inspection readiness.

Requirements

• Track all deviations and investigations related to PV
• Ensure Inspection Readiness of the PV department
• Create and maintain Safety Data Exchange Agreement (SDEA) with Business Partners
• Be the PV point of contact (POC) for commercial, market research, patient support / assistance program to evaluate contractual obligations of PV language and AE / PQC training to Third Party Vendors
• Maintain all contracts related to PV department
• Create and update a company reconciliation tracker to maintain all ICSR reconciliations for Market Research, PAP, PSP, social media, company websites, company social media
• Develop and maintain KPIs and QC process for all vendors performed processes
• Perform AE / PQC training to the relevant Third-Party Vendors
• Develop a robust process to monitor the safety mailbox and maintain the oversight
• Update or create PV-related quality documents
• Assist data entry tasks daily

Benefits

• Annual bonus
• Significant equity
• Generous benefits package