Senior Product Safety Specialist/Manager, Product Safety and Pharmacovigilance

Full time Full day
Gaithersburg, MD

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 Senior Product Safety Specialist/Manager to join our Product Safety and Pharmacovigilance Department. Primary responsibilities include performing and overseeing case processing activities to include processing of all appropriate information regarding adverse event data with thorough and strict adherence and compliance with all relevant global regulations. Responsibilities also include development of Safety Management Plans for study specific workflow, perform reconciliation of safety data, and assist in the development of new standard operating procedures and work instruction documents. The Senior Product Safety Specialist/Manager will be required to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines.

The position will report to the Associate Director/Director of Product Safety and Pharmacovigilance.

Responsibilities include but are not limited to:

  • Provides support to the PV study manager in the operational oversight of CROs performing PV safety activities, including case processing

  • Initiates urgent follow-up activities to CROs or investigative sites to retrieve missing information, according to AE/SAE reporting requirements, regulatory guidelines, and department SOPs.

  • Track cases processed by CROs or in-house to completion to ensure adherence with established case processing timelines.

  • May serve as lead Safety representative in clinical study team projects.

  • Interacts with internal cross-functional leadership or outside of the company.

  • Actively participates in the development and implementation of Safety Management Plans for study-specific workflow.

  • Mentor newly-hired junior PV team members.

  • Other related administrative responsibilities and duties, as required by business need and/or assigned by manager.

Minimum Requirements:

  • Bachelor's Degree in scientific-related field with a minimum of 5 years or Master's Degree in scientific-related field with a minimum of 3 years of related experience 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.

Additional Desirable Skills:

  • A thorough working knowledge of U.S. and international regulations in relation to clinical trial requirements with proven understanding of applying regulations in support of clinical trial activities.

  • Familiarity with use of safety databases including simple searches and safety report data entry and familiarity with medical terminology and MedDRA coding.

  • Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.

  • Strong attention to detail and accuracy

  • Good organizational and prioritization skills to perform a variety of tasks simultaneously, including those with set deadlines

  • Flexibility and ability to adapt and learn quickly

  • Understanding of third-party agreements and ability to apply to clinical trial activities

  • Excellent written and verbal communication skills

  • Good interpersonal skills (i.e. team player)

  • Good Outlook, Microsoft Word and Excel skills

  • Demonstrates initiative and completes assigned tasks with supervision

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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