If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.
We are seeking a motivated and experienced individual to coordinate and lead a variety of Pharmacovigilance (PV) activities with a primary focus on development and oversight of the necessary processes to ensure the collection, processing, and compliant reporting of individual case safety reports (ICSR) to regulatory agencies and business partners in accordance with global PV regulations. The Case Processing Lead acts as a subject matter expert on global PV regulations and case processing best practices relevant to safety reporting. Experience with vaccine case processing is preferred. This position will be located at our Gaithersburg, MD facility and will report to the Sr. Director, Product Safety and Pharmacovigilance Operations. Remote employment will be considered for the ideal candidate.
Responsibilities include but are not limited to:
- Development and management of postmarketing ICSR processing and reporting SOPs, Work Instructions, and Templates.
- Oversee implementation and monitoring of processes pertaining to ICSR processing and reporting to regulatory agencies and business partners in accordance with PV regulations.
- Ability to develop and provide safety reporting training.
- Ability to direct and oversee an ICSR processing team, working cross-functionally to maintain standards for PV activities to ensure patient safety and adherence to global regulations.
- Performing critical team and/or vendor oversight to ensure all PV activities are performed in an efficient, consistent and compliant manner.
- Effectively collaborate with and support key internal and external cross functional stakeholders (Medical Affairs, Clinical, Regulatory, Business Partners, etc.) on clinical trials, investigator sponsored research programs, market research surveys, etc. to ensure PV compliance oversight.
- Support and participate in Signal Detection and Risk Management planning activities.
- Support and participate in Safety Review Team meetings.
- Work with PV Compliance to monitor KPIs, maintain PV inspection readiness, and act as subject matter expert during PV inspections/audits.
- Support Aggregate Reporting Teams with development of PBRERs, PADERs, DSUR, etc.
- Support Safety Data Exchange Agreement negotiations with Business Partners.
- Bachelor's Degree in scientific related field with minimum of 8-10 years of pharmacovigilance experience
- A proven track record in PV with several examples of leading postmarketing 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.
- A minimum of 5 years working for a (bio)pharmaceutical company/CRO in Safety and Pharmacovigilance, across multiple programs in support of phase 1 to phase 3 global clinical trials and post-marketing.
Additional Desirable Skills
- Strong attention to detail and persistence in following tasks through to completion.
- Proficiency with standard office software (Microsoft Office).
- Excellent verbal and written communication skills in English.
- Postmarketing PV experience with vaccines.
- Experience with ARISg safety database.
- Experience managing vendors and/or internal staff.
- Experience developing PV Agreements with business partners.
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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