Associate Director, Product Safety and Pharmacovigilance
Novavax Gaithersburg, MD
- Expired: over a month ago. Applications are no longer accepted.
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 serve as Associate Director, Product Safety and Pharmacovigilance in support of a growing number of clinical stage vaccine development programs. This position will focus on pharmacovigilance operational aspects to support global pre/post-marketing programs as well as oversight of day-to-day safety activities performed by a Contract Research Organization (CRO).
This position will report to the Director, Product Safety and Pharmacovigilance.
Responsibilities include but are not limited to:
- Provide operational oversight of CROs performing safety activities, including case processing
- Serve as PV primary point-of-contact for assigned clinical trial.
- Exercise independent judgment in managing case processing performed by CROs or in-house personnel.
- Interact with internal cross-functional leadership or outside of the company.
- Provide SAE Reporting training, as needed.
- Participate in the maintenance of a serious adverse event management system
- Lead development and implementation of standardized practices and procedures to support organizational objectives and to ensure global regulatory compliance
- Lead and/or support the development of aggregate reports
- Participate in the development and management of Safety Data Exchange Agreements
- Train/Mentor newly-hired PV team members.
- Other related administrative responsibilities and duties, as required by business need and/or assigned by manager
- Bachelor's degree with at least ten (10) years of global pharmacovigilance experience in a regulated pharmaceutical or biotechnology industry.
- Experience in all PV operational activities (i.e., triage, case processing, SAE reconciliation, vendor management) required to ensure efficiency and compliance.
- Working knowledge of U.S. and international regulations for safety reporting in the clinical trials environment.
- Familiarity with medical terminology, summarizing and presenting medical data, and with coding systems for safety data.
- Previous experience in managing small teams, preferred.
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.
- Strong 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.
- Excellent attention to detail and accuracy and persistence in following tasks through to completion
- Strong 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
- Good interpersonal skills (i.e. team player)
- Proficiency with standard office software (Microsoft Office)
- Demonstrated decision-making, organizational, prioritization and problem-solving skills
- Capability to work on multiple projects and meet deliverable timeline
- Ability to work independently and utilize effective planning to support organizational goals and individual goal achievement
- Ability to communicate clearly, concisely, and effectively to express information in both written and oral context.
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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