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Axsome Therapeutics, Inc. · 4 months ago

Senior Manager, Pharmacovigilance Operations

New York, NY

Full-time

Onsite

Senior Level

$140K/yr - $160K/yr

5+ years exp

Axsome Therapeutics is a biopharmaceutical company focused on advancing treatments for central nervous system conditions. They are seeking a Senior Manager, Pharmacovigilance Operations to oversee the PV Compliance system, develop KPIs, and ensure inspection readiness while working cross-functionally with various departments.

BiopharmaBiotechnologyTherapeutics

Responsibilities

Track all deviations and investigations related to PV; ensure the closure of CAPAs in a timely manner

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

Qualification

Pharmacovigilance OperationsCase ProcessingRegulatory RequirementsSignal DetectionICH E2B SpecificationsGlobal Reporting RulesMedical TerminologiesProject ManagementAttention to DetailCommunication Skills