Aggregate Safety Reporting Manager, 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 Aggregate Safety Reporting Manager, Global Vaccine Safety, will be an individual contributor responsible for managing and contributing to the aggregate safety reporting activities as an individual contributor for Novavax products at all stages of the product life cycle (development to post-marketing). This includes facilitating all aspects of aggregate safety reporting. 

Responsibilities include but are not limited to:

  • As an individual contributor, provides pharmacovigilance (PV) data analysis, authoring, and quality control (QC) expertise for the preparation of a range of global regulatory aggregate safety reports (ASR) including Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit‑Risk Evaluation Reports (PBRER), complementary Monthly Summary Safety Reports (MSSR) / Summary Safety Reports (SSR), and Regulatory Authority Assessment Report(s) responses
  • Collaborates with various stakeholders to ensure that outputs from the Novavax safety database meets the need for preparation through submission of ASRs maintaining compliance with regulatory timeline(s)
  • Supports vendor oversight to create the required ASRs including PADER, DSUR, PSUR/PBRER, MSSRs/SSRs and other required aggregate safety analyses / responses 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 PV regulations related to aggregate safety reporting

Minimum Requirements:

  • Bachelor’s degree in Nursing/pharmacy with 4+ years’ Safety and PV experience or a Master’s degree in Health Sciences with 3+ years’ Safety and PV experience in a biotechnology or pharmaceutical company or a PharmD/PhD/MD in a relevant scientific discipline with 3+ years’ Safety and PV experience
  • In-depth knowledge of global PV regulations (i.e., ICH, EMA, FDA, etc.) related to aggregate safety reports (clinical and post-marketing)
  • Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety management plans (SMP), and safety data exchange agreement(s) (SDEA) / Pharmacovigilance Agreement(s) (PVA)
  • In-depth knowledge of clinical trial methodology, PV regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements
  • Experience vendor collaboration
  • Experience interacting with health authorities (e.g., audits, inspections, responses) and CAPA management process(es)
  • Experience in interpreting, synthesizing, and communicating complex safety information
  • Experience with safety database(s) (e.g., ARGUS, ARISg) and MedDRA
  • Experience with the development and maintenance of procedural documents (i.e., standard operating procedures [SOP], work instructions [WI], and templates [TP], forms [FM])

Preferred Qualifications:

  • Experience in global pharmaceutical/biotechnology company, with special reference to vaccines and/or immunotherapeutics
  • Proven experience working in/managing post-marketing safety surveillance
  • Strong attention to detail with a proactive persistence approach to following tasks through to completion
  • Working with clinical research organization(s) (CRO), vendors, and license partner(s).
  • Proficiency with standard office software (Microsoft Office [i.e., Word, Excel, PowerPoint]) and formatting documents
  • Good project management, organizational, documentation, communication, and prioritization skills
  • Good interpersonal and people soft skills (i.e., team player, training, mentoring).
  • 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 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.