• 28-May-2021 to 28-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.

The Senior Pharmacovigilance Scientist will be responsible for providing pharmacovigilance functional area expertise and support to project teams assigned to developmental and/or marketed products. This includes participating in safety review activities, managing the cross-functional assessment of the benefit-risk profile and, communication of safety information to internal and external stakeholders. This position will generate or provide input to safety documents and reports to be submitted to regulatory authorities.

This position will report to the Sr. Director, Safety Surveillance.

Responsibilities include but are not limited to:

  • Provides support for developmental/approved products in close collaboration with senior PV and Clinical personnel
  • Coordinates and plays a critical role in internal safety meetings
  • Facilitates ongoing safety surveillance, assisting with data collection and assessment for internal safety meetings
  • Partners with cross-functional colleagues to gather and provide input for appropriate sections of critical safety/regulatory documents
  • Participates in evaluation of potential safety issues in conjunction with senior PV staff and other functional areas as appropriate
  • Participates in writing of aggregate safety reports
  • Participates in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate

Minimum requirements:

  • PharmD/PhD in relevant scientific discipline with 5+ years' experience in Safety and Pharmacovigilance working on global clinical trials in a biotechnology or pharmaceutical company. Masters with 10+ years' experience or Bachelor's degree with 13+ years' experience
  • PharmD/MSc/PhD in scientific field preferred
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
  • Experience in the preparation and authorizing of individual and aggregate safety reports as well as other clinical/regulatory documents
  • Working knowledge of MedDRA

Additional desirable skills

  • Experience in global pharmaceutical/biotechnology company, with special reference to vaccines and/or immunotherapeutic, and preparation of risk management plans, aggregate reports and other company core safety documents
  • Proven experience working in/leading (safety &/or scientific) pre- and post-authorization 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 independently
  • 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. #LI-Remote #LI-GS1


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