Associate Director, Safety Surveillance, Global Vaccine Safety


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**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.

The Associate Director, Safety Surveillance, Global Vaccine Safety 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.

Responsibilities include but are not limited to:

  • Supports development of PV strategy for product(s) in various stages of development through input and delivery of safety documents and regulatory reports
  • Provides support for developmental/approved products in close collaboration with senior PV and Clinical personnel
  • Plays a significant role in coordination of internal safety meetings
  • Performs ongoing safety surveillance for assigned product(s), assisting with data collection and assessment for internal safety meetings
  • Supports authoring of safety evaluations for aggregate safety reports and ad hoc reports such as Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses
  • 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
  • Authors assigned sections 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

Preferred Qualifications:

  • Experience in global pharmaceutical/biotechnology company, with special reference to vaccines and/or immunotherapeutics, 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 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.