Senior Associate, Safety and Pharmacovigilance

4 weeks ago


Bethesda, Maryland, United States Technical Resources International Full time
Job Summary

We are seeking a highly motivated and detail-oriented Pharmacovigilance Associate to join our team at Technical Resources International. As a key member of our Medical Affairs department, you will be responsible for managing and processing all Serious Adverse Events (SAEs) in accordance with project-specific instructions.

Key Responsibilities:

  • Manage and process all SAEs as per project-specific instructions
  • Document control: maintain electronic files for the department, perform file case searches, maintain file room for the department, and use department databases to track, manage, and control issued documents
  • Track and process assigned pharmaceutical and Data Management Center (DMC) queries
  • Assist in the preparation of contract-required reports
  • Generate specified data reports from the safety database as requested
  • Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required
  • Distribute Safety Information according to project-specific requirements
  • Assist in processing of MedDRA coding tasks
  • Perform QC on AE submissions

Requirements:

  • Ability to analyze medical research data, review experimental protocols, and summarize safety data
  • Familiarity with medical terminology
  • Excellent attention to detail, verbal and written communication skills
  • Superior organizational skills and customer service abilities
  • Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus
  • General knowledge of the drug and vaccine development process or clinical trials is a plus

We are an equal opportunity/affirmative action employer, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.



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