**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, Global Vaccine Safety (GVS) Operations is responsible for leading the execution of post-marketing operational processes. The position may act as a subject matter expert on global pharmacovigilance (PV) regulations and case processing best practices relevant to safety reporting or provide oversight of critical PV quality initiatives. This position will focus on leading PV operational aspects to support global post-marketing programs as well as oversight of day-to-day safety activities performed by a Contract Research Organization (CRO).
Responsibilities may include some or all of the following tasks based on specific job role:
- Develop and manage SOPs, Work Instructions, and Templates
- Lead activities related to deviations/CAPAs
- May act as an individual contributor or as a team leader
- Work with GVS Compliance to maintain inspection readiness and act as subject matter expert during inspections/audits
- Represent Post-marketing Operations as SME for quality and compliance related activities, or ICSR processing activities
- Serves as liaison between Post-marketing Operations and internal stakeholders to identify process improvements or new business needs, provide recommendations, and support implementation. May also serve as liaison between post-marketing operational teams and other teams within Global Vaccine Safety for Safety system configuration and PV input into SDEA
- Partner with GVS Compliance in training curriculum initiatives related to PV vendor
- Lead activities related to vendor oversight including contributing to KPI development and monitoring, contributing to or creating communication and escalation plans between vendor and post-marketing operations, and performing critical vendor oversight to ensure all activities are performed in an efficient, consistent, and complaint manner
- Lead implementation and monitoring of processes pertaining to ICSR processing and reporting to regulatory agencies and business partners or vendor compliance metrics in accordance with PV regulations
- Partner with Novavax Quality Assurance and GVS Compliance to ensure the vendor PV Quality Agreements and related documentation are developed and executed and the implementation of an associated PV quality monitoring plan
- Leads the review of key operational documents (e.g., safety management plans, data entry manual) to ensure alignment of processes and identify areas for improvement or clarity
- Support management of vendor contracts
- Support Signal Detection and Risk Management planning activities
- Support Aggregate Reporting Teams with development of PBRERs, PADERs, DSUR, etc.
- Support deliverables outlined in SDEAs, collaborate with internal stakeholders to ensure oversight, evaluation, and awareness of new programs/changes to ongoing programs, and support maintenance and negotiation of adverse event in reconciliation language with third party vendors for applicable studies/programs to ensure compliance
- Perform other tasks as assigned by management of Post-marketing Operations
- Bachelor's Degree in scientific related field with minimum of 10 years of pharmacovigilance experience. Healthcare professional [RN or Pharmacist] preferred.
- A proven track record in PV with several examples of leading post-marketing PV activities
- Expert in MedDRA coding
- Demonstrated ability to apply principles, concepts and industry best practices governing PV in assigned projects and company deliverables
- In depth knowledge of global safety reporting activities, regulations, guidance, and ICH/GXP guidelines
- Experience developing of SOPs, Templates, and Working Practices.
- Excellent written and verbal communication skills
- Strong interpersonal skills and ability to manage, motivate and influence work behaviors of individuals who are not direct reports
- Highly organized, outcome oriented, problem solving, understanding of research methods and basic data analysis, excellent teamwork, and strong communication skills
- Post-marketing PV experience with vaccines
- Excellent verbal and written communication skills in English
- Experience managing vendors and/or internal staff
- Proficiency with standard office software (Microsoft Office)
- Experience directly managing staff or teams
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.