About the position
Axsome Therapeutics is seeking an Associate Director, Pharmacovigilance (PV) Operations to manage individual case safety reports (ICSRs) from receipt of source documents and appropriate submissions to relevant Health Authorities globally. The Associate Director, PV Operations is responsible for oversight of the case processing activities of PV Service Providers, ensuring timely expedited submission of ICSRs to relevant Health Authorities, developing relevant key performance indicators for compliance monitoring, and ensuring robust and efficient case processing systems. The Associate Director, PV Operations will report directly to the Senior Director, PV Operations and will work cross-functionally with different departments, including Clinical Development, 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.
Responsibilities
- Oversee the vendor case processing activities to ensure the quality of safety cases
- Perform both real-time and retrospective quality control of safety case data entry to ensure quality and compliance with the data entry conventions and MedDRA/WHO DD coding conventions
- Trend the case quality of both investigational and approved products and communicate to the case processing vendor
- Develop and review Quality Control reports to identify trends in ICSR related criteria, such as invalid cases, spot data entry errors
- Ensure ICSR reconciliations are performed with the relevant parties in a timely manner
- Participate in vendor quality meetings and governance meetings
- Oversee the vendor case processing activities to ensure compliance with regulatory submissions and internal timelines including monitoring the workflow status of safety cases and or the pending regulatory submissions of ICSRs
- Analyze and investigate for late forwarding, data entry, submission/distribution of safety reports, as applicable
- Support the authoring or review of the periodic safety reports to ensure timely submissions
- Perform and oversee reconciliations with internal/external stakeholders to ensure cases are exchanged as per the relevant agreement
- Provide input on behalf of PV Operations on individual study-specific documents including but, but not limited to, Safety Operational Management Plan, SAE Reconciliation Plan, Data Validation Plan, and Safety Reporting Form Specifications Document
- Support the set-up and maintenance of individual study-specific activities, including, but not limited to Market Research Projects, Patient Support Programs, Patient Assistance Program, Clinical Trials, etc.
- Support and provide guidance on questions concerning PV Operations based on, not only company conventions, but also regulatory guidance from Health Authorities
- Contribute to the creation or updating of Standard Operating Procedures, Working Instructions, and training materials concerning safety case processing and operations
- Support Axsome initiatives and projects representing PV Operations
Requirements
- Bachelor’s degree required. A Master’s degree in Science, or other Health Care Professional degree preferred i.e., MSn, RN, PharmD
- 8+ years of experience in Pharmacovigilance Operations
- Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management
- 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.
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Nice-to-haves
- Some experience in signal detection
- 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 EDC for clinical trial data collection is a plus but not mandatory
- Excellent in detailed-oriented tasks
Benefits
- The anticipated salary range for this role is $170,000 - $195,000
- Annual bonus
- Significant equity
- Generous benefits package
