Novavax
  • 29-Aug-2017 to 28-Oct-2017 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.   Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.  

 Overview:

 We are seeking a Senior Product Safety Specialist 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 may 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 will be required to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines. The position will be located at our Gaithersburg, MD facility and will report to the Sr. Director of Product Safety and Pharmacovigilance.

 Responsibilities include but are not limited to:

  • Perform case handling activities in compliance with Good Clinical Practices (GCP) and global regulatory requirements.
  • Initiate urgent follow-up activities to investigative sites to obtain critical information, as needed
  • Track cases to completion to ensure adherence with established case processing timelines.
  • Manage day-to-day interactions with investigative sites and provide guidance/training, as needed.
  • Ensure all safety reports are triaged, processed, and reported according to global regulatory requirements and Novavax SOPs, for assigned study
  • Assist in training new team members on the safety database

 Minimum Requirements:

  • Health Care Professional (HCP) or Bachelor's Degree in scientific related field.
  • A minimum of 5 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.

 Additionally, we prefer candidates that have:

  •  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
  • 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 Rockville, Maryland and Uppsala, Sweden and employs over 300 individuals dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

 

Novavax
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