• 13-May-2021 to 14-Jun-2021 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking an Associate Director, Aggregate Safety Reporting, who will be responsible for leading the aggregate safety reporting activities for Novavax products at all stages of the product life cycle (development to post-marketing). This includes facilitating all aspects of aggregate safety reporting.

This position will report to the Senior Director, Pharmacovigilance Risk Management.

Responsibilities include but are not limited to:

  • Leads the development and implementation of an aggregate safety reporting system.
  • Manages the strategic and operational aspects of aggregate safety reporting.
  • Provides pharmacovigilance data analysis and writing expertise as required for preparation of a range of global regulatory reports including PADER, DSUR, PSUR/PBRER, and
  • complementary summary monthly safety reports
  • Collaborates with various stakeholders to ensure that outputs from the Novavax safety database meets the need for preparation of aggregate safety reports (ASRs)
  • Maintains vendor oversight to create the required documents including PADER, DSUR, PSUR/PBRER, and other required aggregate safety analyses required by regulatory authorities.
  • Coordinates review/approval of ASRs e.g., leads resolution of safety issues and mediates cross-functional agreement.
  • Ensures safety issues are communicated to the appropriate stakeholders in a timely fashion.
  • Understands current industry best practices and builds in-depth knowledge of global pharmacovigilance regulations related to aggregate safety reporting.

Minimum requirements:

  • PharmD/PhD in relevant scientific discipline with 3+ years' experience in Safety and Pharmacovigilance in a biotechnology or pharmaceutical company
  • Masters with 7+ years' experience or bachelor's degree with 10+ years' experience PharmD/MSc/PhD in scientific field preferred
  • Expert in global pharmacovigilance regulations related to aggregate safety reports.
  • In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements
  • Experience interacting with health authorities, e.g., audits and inspections
  • Thorough understanding of approaches to aggregate safety reporting
  • Experience in interpreting, synthesizing and communicating complex safety information

Additional desirable skills:

  • Experience in global pharmaceutical/biotechnology company, with special reference to vaccines and/or immunotherapeutics
  • Proven experience working in/leading Post-Marketing safety surveillance
  • Strong attention to detail and persistence in following tasks through to completion
  • Proficiency with standard office software (Microsoft Office)
  • Good organizational and prioritization skills
  • Good interpersonal skills (i.e., team player)
  • Ability to work with limited supervision
  • Flexibility and ability to adapt and learn quickly
  • Ability to work under pressure and to tight deadlines
  • Excellent communication and presentation skills in English (both written and spoken)

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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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