Vice President, Head of Safety Operations and Compliance, Global Vaccine Safety

Company: Novavax
Location: Gaithersburg
Posted on: March 20, 2023

Job Description:

If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. The Head of Safety Operations and Compliance, Global Vaccine Safety is responsible for planning, implementing strategy and management of all Global Vaccine Safety Operations and Compliance activities as well as safety systems supporting the Global Vaccine Safety function and deliverables. This position works in a matrix environment with multiple other departments across the organization, and with external stakeholders such as business partners and service providers. The position reports to the Senior Vice President, Chief Safety Officer, Global Vaccine Safety. Responsibilities include but are not limited to : Provide leadership, strategic consultation, and guidance to maintain standards for operational, compliance, vendor oversight, and systems activities Develop and maintain infrastructure to support the company's developmental and commercial pipeline, including hiring of staff, development of operating plans and budgets and allocation of resources to ensure budgets, schedules, and performance requirements are met In partnership with the QPPV Office, provide strategic direction for operational activities to ensure compliance with global regulations and to ensure a quality Pharmacovigilance (PV) System Oversight of service providers to ensure effectiveness, quality, and compliance of outsourced activities Foster collaboration across the organization including business partners and service providers to support effective end-to-end PV processes Key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics Minimum Requirements: Bachelor's degree in life sciences or related discipline with a minimum of 15 years' experience in Safety and Pharmacovigilance including but not limited to working on global clinical trials and launches in biotechnology or pharmaceutical company 10 years demonstrated experience in a PV leadership role with strong operational and strategic components Medical or relevant advanced degree strongly preferred Proven track record in creating, building, and leading a high-quality Pharmacovigilance function within the complex global regulatory pharmacovigilance environment Ability to comprehend and synthesize complex data and experience in the identification, analysis and implementation of program and procedures required to achieve corporate objectives Experience with CROs, vendors, and relationship management High degree of internal and external customer focus Focus on immediate and urgent business needs while driving long term strategic plans and capability and organizational development Provide strategy, vision, and direction regarding issues that may have company-wide impact Requires in-depth knowledge of the functional area, business strategies, and the company's goals. Thorough understanding of Good Pharmacovigilance Practices and Good Clinical Practices Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law. Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Novavax, Washington DC , Vice President, Head of Safety Operations and Compliance, Global Vaccine Safety, Executive , Gaithersburg, DC