Senior Manager, Pharmacovigilance Operations

Axsome Therapeutics • New York, NY

117d • $140,000 - $160,000

About The Position

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. The Senior Manager, PV Operations will report directly to the Senior Director, PV Operations and will work cross-functionally with different departments, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Requirements

• Bachelor’s degree required. Master’s degree in science, and other health care professional degree preferred
• 5+ years of experience in Pharmacovigilance Operations
• Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management
• Some experience in signal detection
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Nice To Haves

• Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
• Knowledge of global pharmacovigilance reporting rules and timelines, including but not limited to Health Canada, FDA and EMA
• Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc.
• Experience with clinical and/or post-marketing case processing, including medical terminologies, MedDRA and WHO DD coding and narrative writing
• Experience with safety database; ARISg is a plus but not mandatory
• Experience with Veeva is a plus but not mandatory
• Excellent in detailed-oriented tasks

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

Benefits

• The anticipated salary range for this role is $140,000 - $160,000
• Annual bonus
• Significant equity
• Generous benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees