Manager/Senior Manager, Safety Epidemiology and Benefit Risk

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**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.**

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.

Summary of the Position:

We are seeking a motivated and experienced individual to serve as Manager, Safety Epidemiology and Benefit Risk in support of a growing number of developmental and marketed vaccine. programs. This position will report to the Vice President, Safety Epidemiology and Benefit Risk in Global Vaccine Safety.

Responsibilities include but are not limited to:

  • Assist and coordinated with planning, design, conduct, analysis and reporting of regulatory-grade epidemiologic post-marketing safety research studies, and real-world evidence (RWE) signal evaluation
  • As needed, assist with observed versus expected analyses, develop epidemiological insight for the reporting and outcomes from VAERS, EudraVigilance and other global spontaneous reporting databases
  • Identification of relevant literature, real world data sources and other assets to characterize disease natural history and topics in vaccine safety
  • Assist with organizing and managing projects involving epidemiologic research plans that are utilized internally and/or support commitments to external agencies and health authorities such as FDA, EMA, CDC, WHO.
  • Contract and manage vendors and/or consultants to meet epidemiology and benefit risk needs
  • Monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency, and industry best practices. Provide compliance support as needed.
  • Maintain working relationships with Novavax cross-functional development teams in the areas of Global Vaccine Safety, regulatory, medical affairs, and other company areas to support epidemiologic matters

Minimum Requirements:

  • Masters or equivalent in pharmacoepidemiology, epidemiology or related health science field and experience in the health care environment.
  • PhD preferred
  • A minimum of 3 years of experience in the pharmaceutical / biotechnology industry with at least 5 years of epidemiology-related experience. Experience with vaccine development is desired
  • Demonstrated understanding of vaccine-related epidemiological topics related to PASS studies, benefit-risk assessments, and/or RWE/RWD projects
  • Experience in supporting the preparation of risk management plans, aggregate reports (e.g., PSURS, DSURs)
  • Self-starter with good organizational, prioritization, and interpersonal skills who will move forward with key initiatives without being prompted and able to perform multiple tasks as needed for timely support to the vaccine development program from an epidemiology perspective
  • Direct experience with tracking, compiling, and analyzing project metrics is must.
  • Excellent communication and presentation skills in English (both written and spoken)

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.

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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)

Job details
Clinical
Novavax HQ
Gaithersburg, Maryland, USA
Remote - US
USA
MANAG003434
Full-time