Senior Manager, Pharmacovigilance Operations

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

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.

Job Responsibilities and Duties include, but are not limited to, the following:

• 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

Requirements / Qualifications

• 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

Experience and Knowledge

• 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

Salary & Benefits (HR will complete)

The anticipated salary range for this role is $140,000 - $160,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.