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Safety and Pharmacovigilence Specialist

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Beacon Hill

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Location:
United States , Bethesda

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Category:
Health and Beauty

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Contract Type:
Employment contract

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Salary:

70000.00 - 85000.00 USD / Year
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Job Description:

SAFETY & PHARMACOVIGILENCE SPECIALIST (2 positions). Hybrid position-2 days in Bethesda, MD office-Mondays/Wednesdays, or Tuesdays/Thursdays-chosen by supervisors. Working hours-8am-4:30pm, or 5pm (Depending on if you take a half hour our hour-long lunch break). Contract Term: 6 months (1000 hrs) to permanent.

Job Responsibility:

  • Ensures compliance with Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
  • Develops and ensures the uniform and timely processing of adverse event reports
  • Provides medical evaluation of adverse event reports
  • Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
  • Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
  • Performs literature searches
  • Performs various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation
  • Preparation of IND safety reports for submission to the FDA
  • safety document or data analysis
  • Clinical trial site support
  • reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
  • Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary
  • May review experimental protocols and informed consent documents
  • and prepare, review, and edit presentations regarding safety issues

Requirements:

  • US OR Foreign Trained MDs (MBBS) – with clinical practicing experience
  • Ideal candidate will have all three, MD + Clinical Practicing experience + clinical research
  • Strong written and oral communication skills
  • Knowledge of GCP and ICH guidelines preferred
  • drug development/clinical trial experience essential
  • Knowledge of safety databases and/or MedDRA coding preferred
  • Experience leading clinical and cross functional teams is a plus
  • Must have excellent oral, written, presentation and computer skills
  • 2+ years of academic, pharmaceutical or biotech industry or academic experience

Nice to have:

  • Knowledge of GCP and ICH guidelines
  • Knowledge of safety databases and/or MedDRA coding
  • Experience leading clinical and cross functional teams

Additional Information:

Job Posted:
April 16, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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