Senior Director Pharmacovigilance Operations

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role

Axsome Therapeutics is currently seeking a Senior Director, Pharmacovigilance Operations. This role is responsible for the oversight of the Pharmacovigilance (PV) Quality Management System including oversight of PV safety vendor activities, leading interactions between pharmacovigilance and other internal departments, monitoring PV quality/compliance activities, and liaising with external partners for the contractual exchange of safety information. This position requires an experienced and accomplished safety operations professional who can provide functional and technical expertise while collaborating with multiple stakeholders. 

This role is based at Axsome’s HQ in New York City. 

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

• Oversight of safety vendor activities including the case processing of adverse events in the global safety database for investigational and approved products; reconciliation of adverse event information with partners and other parties, and the production of a variety of safety reports 
• Oversight of submissions of expedited reports to the FDA & other health authorities 
• Develop standard procedures and guidelines for safety operations 
• Participate in the creation of cross-functional Pharmacovigilance procedures 
• Effectively utilize Key Performance Indicators and other metrics to assess compliance, productivity, opportunities for quality improvement, and to measure effectiveness of change initiatives 
• Proactively lead case processing/ case quality improvement initiatives 
• Fully support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with the Quality organization 
• Negotiate safety data exchange agreements and processes with business partners 
• Provide support and subject matter expertise during audits and inspections
• Ensure readiness and management of FDA inspections
• Represent drug safety on project teams, other departments, and committees as needed 

 Requirements / Qualifications  

• Bachelor’s degree required. Advanced degree or health care certification preferred 
• Minimum 10-12 years of experience in the pharmaceutical/biotechnology industry 
• Minimum 6-8 years of experience in pharmacovigilance operations 
• Expert in Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, including knowledge of case processing, expedited reporting rules, and safety database concepts
• Prior experience overseeing or interacting with an external safety vendor required
• Ability to work on site Monday, Tuesday & Thursday

Experience and Knowledge 

• Strong expertise with safety databases  
• Prior experience negotiating/reviewing PV safety exchange agreements 
• Previous experience in drug safety pre-approval (ranging from early to late-stage) and in the post-marketing setting 
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues 
• Prior supervisory experience and mentorship of junior colleagues
• Strong organizational skills, including the ability to prioritize independently with minimal supervision and collaborate to problem solve
• Excellent verbal and written communication skills including ability to present to both internal and external partners
• Strong working knowledge of tools such as Microsoft Office and other project management applications 

Salary & Benefits  

The anticipated salary range for this role is $245,000 - $260,000. 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.