Pharmacovigilance Scientist

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 Pharmacovigilance Scientistto establish and execute pharmacovigilance (PV) systems and procedures, with a strong focus on maintaining high-quality standards. This roleis responsible for supporting the Pharmacovigilance (PV) Science function under the guidance of the PV physician and providing oversight of ICSR assessment, signal detection, medical surveillance and risk management activities for investigational products in clinical development and marketed products. This position collaborates with key internal stakeholders, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers and partners on pharmacovigilance-related matters.

This position reports to Executive Director of Pharmacovigilance/Drug Safety and 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:

• Assist safety physician to enhance safety surveillance and signal detection by monitoring and analyzing safety data from various sources to identify potential safety signals or trends related to investigational and marketed products
• Contribute to the creation and execution of risk minimization measures to mitigate identified risks.
• Support the preparation pharmacovigilance aggregate safety reports (e.g., PADER, PSURs, DSURs) to regulatory authorities to meet compliance requirements.
• Collaborate with PV physician/PV operations and key stakeholders to request/receive applicable sections of the report
• Provide training and guidance to other functions to address ad hoc questions and issues
• Ensure timely finalization of the reports to meet the submission timelines of relevant health authorities and other external stakeholders
• Collaborate and communicate with cross-functional teams to ensure effective safety monitoring and communication
• Support the safety review team (SRT) and coordinates all safety topic discussion and documentation.
• Ensure appropriate stakeholder representation and input at SRT
• Ensure all data is appropriately compiled and presented at SRT for team review
• Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications etc.)
• Contribute to clinical trials by providing safety input and reviewing documents such as Clinical Study Reports (CSRs), protocols, and investigator brochures (IB), ICF etc.
• Provide support for the processing of individual case safety reports (ICSRs) and ensure data accuracy and completeness for investigational and marketed products
• Support the PV SOP updates
• Oversee vendor safety process, e.g., signal detection, validation and assessment.
• Participate in audit/inspection preparedness activities and provide support during regulatory inspections in collaboration with team members
• Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAR reconciliation, un-blinding process, and safety reporting training
• Evaluate and improve current PV processes, as needed, to strengthen medical surveillance and risk management process ensuring alignment with best practices

Requirements / Qualifications

• Master's degree in health-discipline or equivalent required, RN, R.Ph, or Pharm D degree is highly preferred
• 5+ years of progressively responsible Pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment with focused experience in signal detection, safety surveillance, risk mitigation and risk management
• Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management
• Experience in submission activities in both FDA and EU is preferred, but not required
• Must demonstrate the ability to draft reports, business correspondence, and procedures, and to effectively present information and respond to questions from internal and external stakeholders, both domestic and international
• 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.
• Knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
• 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 assessment, including medical terminologies, MedDRA and WHO DD coding and narrative writing.
• Experience with safety database is required; ARISg is a plus but not mandatory.
• Experience with Veeva is a plus but not mandatory.
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
• Excellent verbal and written communication and skills
• Excellent in detailed-oriented tasks.

Salary & Benefits

The anticipated salary range for this role is $150,000 - $185,000. 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.