Director of Pharmacovigilance

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Director of Pharmacovigilance to join our growing team! This position can be based at our South San Francisco office or remote (U.S. based).

Summary:

The Director of Pharmacovigilance is responsible for providing direction and oversight for all drug safety and pharmacovigilance activities, including signal detection/evaluation and risk management. The individual in this role will partner with the CMO and Medical Monitor(s) to oversee all operational aspects for safety and pharmacovigilance, including development and implementation of relevant processes in compliance with local, regional, and global regulatory requirements and execution of these processes for all of Vaxart’s vaccine trials.

Responsibilities:

• Organize and oversee medical reviews of individual case safety reports for serious adverse events (SAE) that occur on any of Vaxart’s clinical trials. Reviews SAE reports, adhering to standard operating procedures for medical assessment of individual case safety reports providing medical safety assessments and pharmacovigilance comments. Triage the reports to medical staff as appropriate to ensure that all cases are analyzed, closed out and documented in compliance with GCP/ICH guidelines.
• Provides safety input to clinical development plans, study protocols, amendments, IB, ICF, CSR, responses to health authorities (HA) or institutional review board (IRB)/ ethics committee (EC) queries.
• Oversee, prepare, and/or review aggregate safety review documents (e.g., DSUR) and safety sections of relevant clinical trial documents (e.g., protocols, CSRs, IBs, ICFs and regulatory filings.
• Facilitates and ensures communication with functions involved with receiving, investigating, or reporting AE’s; supports cross-functional study and program teams.
• Leads the evaluation & management documentation of signals emerging from any data source. Develops strategies for signal evaluations (e.g., case-series, literature review, HA/ claims database).
• Makes contributions to process improvement, particularly with adverse event processing and operational aspects of medical reviews.
• Coordinates and supports medical review meetings and other cross functional meetings on clinical safety with other groups as well as any relevant ad hoc safety related projects.
• Leads safety activities and benefit-risk strategies for assigned compounds/programs. Establish and chair the product Safety Management Teams as required.
• Assists the team and senior management in all forms of safety related issue management.

Requirements:

• MD or PhD with a minimum of 8 years of progressive clinical development experience in pharmacovigilance, at a pharmaceutical or biotechnology company.
• 8+ years of experience in pharmaceutical safety including a thorough understanding of safety operations and global regulatory requirements, and broad understanding of downstream activities including signal detection and risk assessment; 10-12+ years of experience highly desirable.
• A minimum of 5 years of project or line management experience overseeing PV staff and/or consultants/CRO’s.
• Broad experience in clinical trial design and safety implementation (Phase 1 to 3) and clinical data interpretation.
• Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, Good Pharmacovigilance Practices (GVP), and ICH Guidelines.
• Experience with extensive working knowledge of MedDRA and Proprietary safety databases.
• Experience managing business processed and outsourcing vendors and relationships.
• Strong relationship building skills, with the ability to interact effectively in a multifunctional, multicultural, growing organization.
• Highly self-motivated and comfortable operating in an entrepreneurial environment as a functional leader and as a member of a team.
• Ability to operate and thrive in a fast-paced environment; demonstrated flexibility, attention to detail, and quality focus.
• Strong organizational, project management, technical and problem-solving skills.
• Well-developed presentation, communication, and interpersonal skills, including strong oral and written communication skills.

Vaccination Requirement:

Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401K with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.