Safety & Pharmacovigilance Specialist

This is a hybrid position with 2 days in Bethesda/Rockville Maryland office, and 3 days working remotely.

Responsibilities

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  Ensure adherence to internal operating procedures as well as regulatory requirements from agencies such as the FDA, WHO, and other global health authorities for adverse event reporting.

  
  
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  Oversee the consistent and timely intake, processing, and documentation of adverse event reports.

  
  
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  Conduct medical review and assessment of adverse event cases.

  
  
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  Support clinical research operations through activities related to adverse event tracking, reporting, data collection, and communication for both marketed products and investigational therapies.

  
  
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  Maintain and update toxicity summary tables related to clinical and preclinical studies for investigational compounds.

  
  
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  Perform scientific and medical literature reviews to support safety assessments and research activities.

  
  
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  Assist with adverse event data analysis, case processing, and reconciliation of serious adverse events across clinical studies.

  
  
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  Prepare safety documentation including Investigational New Drug (IND) safety reports and related analyses for submission to the FDA.

  
  
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  Provide support to clinical trial sites by facilitating the reporting, collection, and communication of safety data and findings.

  
  
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  Contribute to the preparation of regulatory safety submissions and documentation, including IND safety updates, New Drug Application (NDA) safety materials, investigator communications, and product labeling information.

  
  
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  Review clinical trial protocols and informed consent forms as needed, and assist in preparing presentations or materials addressing drug safety considerations.

  
  

Qualifications

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  Familiarity with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines preferred.

  
  
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  Prior experience in drug development and/or clinical trial environments required.

  
  
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  Experience working with pharmacovigilance safety systems and MedDRA coding is advantageous.

  
  
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  Ability to collaborate across clinical and cross-functional teams; leadership experience is a plus.

  
  
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  Strong written, verbal, presentation, and computer proficiency.

  
  
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  Minimum of 2 years of experience in an academic research setting, pharmaceutical company, or biotechnology organization.

  
  

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.